A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered 83-0060 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Volunteers Only
- Sponsor
- Traws Pharma, Inc.
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Incidence of AEs
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of 83-0060 in Healthy Volunteers
Detailed Description
This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered 83-0060 in Healthy Volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) part at up to 5 dose levels and a multiple ascending dose (MAD) part at up to 3 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- •Adult males and females, 18 to 65 years of age (inclusive) at screening.
- •Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.
Exclusion Criteria
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant.
- •History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study.
- •Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
- •Presence or history of any abnormality or illness, including gastrointestinal surgery, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug.
- •Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
- •Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.
Arms & Interventions
Single dose level 4 or placebo
Dose level 4. SAD study part.
Intervention: Placebo
Multiple dose level 3 or placebo
Dose level 3. MAD study part.
Intervention: Placebo
Single dose level 5 or placebo
Dose level 5. SAD study part.
Intervention: 83-0060
Single dose level 5 or placebo
Dose level 5. SAD study part.
Intervention: Placebo
Multiple dose level 1 or placebo
Dose level 1. MAD study part.
Intervention: 83-0060
Multiple dose level 1 or placebo
Dose level 1. MAD study part.
Intervention: Placebo
Multiple dose level 2 or placebo
Dose level 2. MAD study part.
Intervention: 83-0060
Multiple dose level 2 or placebo
Dose level 2. MAD study part.
Intervention: Placebo
Multiple dose level 3 or placebo
Dose level 3. MAD study part.
Intervention: 83-0060
Single dose level 4 or placebo
Dose level 4. SAD study part.
Intervention: 83-0060
Single dose level 1 or placebo
Dose level 1. SAD study part.
Intervention: 83-0060
Single dose level 1 or placebo
Dose level 1. SAD study part.
Intervention: Placebo
Single dose level 2 or placebo
Dose level 2. SAD study part.
Intervention: 83-0060
Single dose level 2 or placebo
Dose level 2. SAD study part.
Intervention: Placebo
Single dose level 3 or placebo
Dose level 3. SAD study part.
Intervention: 83-0060
Single dose level 3 or placebo
Dose level 3. SAD study part.
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of AEs
Time Frame: 8 days in SAD part, 17 days for MAD part
Incidence of Adverse Events observed during the study
Incidence of drug-related AEs
Time Frame: 8 days in SAD part, 17 days for MAD part
Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator
Incidence of SAEs
Time Frame: 8 days in SAD part, 17 days for MAD part
Incidence of Serious Adverse Events observed during the study
Incidence of lab deviations
Time Frame: 8 days in SAD part, 17 days for MAD part
Incidence of clinically relevant deviations in the clinical laboratory parameters
Secondary Outcomes
- Plasma concentration(8 days in SAD part, 17 days for MAD part)