NCT07266207
Completed
Phase 1
A Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Food Effects of ARD-885 Film-coated Tablets in Healthy Chinese Subjects and Patients With Rheumatoid Arthritis
Artivila (Shenzhen) Innovation Center, Ltd1 site in 1 country94 target enrollmentStarted: December 16, 2024Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Artivila (Shenzhen) Innovation Center, Ltd
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Adverse Events (AE)/Severe Adverse Events (SAE)
Overview
Brief Summary
The proposed study is a randomized, double-blind, placebo-controlled single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetic, and food effects of ARD-885 Film-coated Tablets in healthy subjects.The entire study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study in healthy subjects.
Detailed Description
The whole study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study. The SAD and MAD studies are randomized, double-blinded, and placebo-controlled studies, and the FE study is a randomized, open-label, two-period, two-treatment (2×2) crossover study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All subjects:
- •Healthy male and female subjects of any ethnic origin between the ages of 18 and
- •Male and female patients with rheumatoid arthritis between the ages of 18 and
- •An informed consent document signed and dated by the subject. Subjects must be willing to understand and comply with all research procedures and restrictions and be able to communicate effectively with investigators.
- •A minimum body weight of 50 kg for males and 45 kg for females, with a body mass index of 18 to 28 kg/m2 for healthy subjects and 18 to 35 kg/m2 for patients with RA.
- •Subject (including partner) agrees to use at least one effective contraceptive method during sexual activity with partner from screening until 3 months after dosing agrees not to participate in sperm or egg donation during the study period until 3 months after the last dosing. See Section 8.1 for specific contraceptive methods.
Exclusion Criteria
- •Known or suspected allergy to any component of ARD-885 Film-coated Tablets, or individuals with a hypersensitivity to allergies (multiple drug and food allergies), as determined by the investigator, and deemed unsuitable for inclusion.
- •Lactating women; Women of reproductive age with menstrual disorders within 90 days before administration; Women of childbearing age who have had unprotected sexual intercourse with an opposite-sex partner in the 28 days before administration. Female subjects who are lactating or have a positive serum pregnancy result during the screening period or during the trial.
- •Participated in any drug clinical trial within 90 days before administration, or the administration date of this study is still within the safety washout period specified in the previous drug clinical trial.
- •Non-physiological blood loss ≥ 200 ml within 60 days before administration (including trauma, blood collection, blood donation); Or plan to donate blood during the trial or within 30 days of administration.
- •Had a major disease that investigators considered clinically significant within 90 days before first administration; Have any active malignancy or history of malignancy in the 5 years prior to screening, with the exception of treated and considered cured skin squamous or basal cell carcinoma, cervical carcinoma in situ, or breast ductal carcinoma in situ.
- •Had major surgery within 60 days of administration, or had any surgery within 28 days of administration.
- •Infectious diseases such like fever and so on within 28 days before administration.
- •Previous use of any of the drugs or treatments listed in protocol.
- •Received vaccine or live attenuated vaccine within 1 month before administration, or who plan to receive the vaccine during the trial period.
- •Those who smoked more than 5 pieces of tobacco or equivalent daily in the 3 months before screening, or drank ≥ 14 units of alcohol per week; Or disagree with the prohibition of smoking or alcohol during the trial; Or positive alcohol serum test during screening or baseline (Day-1).
Arms & Interventions
ARD-885 Tablets (Multiple Administration Dose, cohort B1~B3)
Experimental
ARD-885 Tablets, 25 mg/50 mg/100 mg, once a day(QD), from Day1~Day7
Intervention: ARD-885 Tablets (Drug)
ARD-885 tablet (Single Administration Dose, cohort A0~A7)
Experimental
ARD-885 Tablets, 5/10/30/60/100/150/200/250 mg，a single dose on Day1
Intervention: ARD-885 Tablets (Drug)
ARD-885 Placebo tablet (Single Ascending Dose, cohort A1~A7)
Placebo Comparator
ARD-885 Placebo tablet, a single dose on Day1
Intervention: ARD-885 Placebo Tablet (Drug)
ARD-885 Tablets (Food Effect, cohort C1~C2)
Experimental
ARD-885 tablets, 50mg, a single dose on Day1 and Day7, fed or fasted crossover
Intervention: ARD-885 Tablets (Drug)
ARD-885 Placebo Tablets (Multiple Administration Dose, cohort B1~B3)
Placebo Comparator
ARD-885 Placebo tablets, once a day(QD), from Day1~Day7
Intervention: ARD-885 Placebo Tablet (Drug)
Outcomes
Primary Outcomes
Adverse Events (AE)/Severe Adverse Events (SAE)
Time Frame: The first day of the first administration until 7 days after the last administration.
Safety and tolerability are assessed by the incidence of adverse events and its severity caused by the study drug during or after dose.
Secondary Outcomes
- PK: Cmax of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: T1/2 of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: Tmax of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: AUC0-t of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: AUC0-last of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: AUC0-inf of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: CL/F of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: Css_max of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: Tss_max of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: RACmax of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: Css_min of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: AUCss_tau of ARD-885.(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PK: RAAUCtau of ARD-885(Pharmacokinetics blood samples were collected from Day1 before administration to 48 hours after the last administration.)
- PD: The concentration of TNF-α(blood samples were collected from 1 hour before first administration to 24 hours after the last administration.)
- PD: The concentration of IL-6.(blood samples were collected from 1 hour before first administration to 24 hours after the last administration.)
- PD: The concentration of IL-1β.(blood samples were collected from 1 hour before first administration to 24 hours after the last administration.)
Investigators
Study Sites (1)
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