A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, andImmunogenicity of RC1416 Injection Via Subcutaneous Administration in Healthy Adult Volunteers.

Nanjing RegeneCore Biotech Co., Ltd.1 site in 1 country48 target enrollmentJune 29, 2023

ConditionsHealthy Volunteers

InterventionsRC1416(SAD)Placebo(SAD)

DrugsRC1416(SAD)Placebo(SAD)

Overview

Phase: Phase 1
Intervention: RC1416(SAD)
Conditions: Healthy Volunteers
Sponsor: Nanjing RegeneCore Biotech Co., Ltd.
Enrollment: 48
Locations: 1
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of RC1416 injection via Subcutaneous Administration in Healthy Adult Volunteers.

Detailed Description

RC1416 is a bispecific homodimer nanobody .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 48 healthy adult subjects will be enrolled in six groups to access the safety and tolerability of single subcutaneous injection of RC1416 in healthy adult subjects.

Registry

clinicaltrials.gov

Start Date

June 29, 2023

End Date

May 14, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nanjing RegeneCore Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 18 to 50 years(including the boundary value)，Chinese.
•Male Weight of 50 kg to 90 kg，femal weight of 40kg to 90kg, and BMI of 19.0 to 28.0 kg/m2 (including the boundary value).
•Subject have no fertility, sperm/egg donation plan for at least 6 months from the signing of the informed consent to the end of the treatment, and voluntarily takes medically recognized effective non-drug contraceptive measures (including his partner) during the trial.

Exclusion Criteria

•Have participated in clinical trials of drugs in other trials within 3 months prior to screening .
•With clinically significant investigator-identified abnormalities of the cardiovascular, respiratory, digestive, endocrine systems (e.g., diabetes), nervous/mental systems, blood, and lymphatic systems (immune deficiency), and musculoskeletal systems.
•With clinically significant infectious disease (e.g., cellulitis, abscess, or systemic infection (e.g., sepsis), or history of clinically significant opportunistic infection (e.g.,invasive candidiasis or pneumocystis pneumonia) within 3 months before to screening.
•With a history of active tuberculosis or the presence of latent tuberculosis infection or active tuberculosis indicated by any current symptoms, signs or laboratory tests.
•Have an allergic constitution, history of allergy to the test drug ingredient or to any drug or food or pollen.
•Received chemotherapy, radiotherapy, immunosuppressive therapy, or high-dose corticosteroid treatment within 5 years before signing the informed consent.
•Use of any prescription, OTC, traditional Chinese medicine, vitamin or health product within 1 month prior to screening;
•Received live or attenuated vaccines within 1 month or have any vaccination schedule during the clinical trial.
•Had surgery within 6 months prior to screening or planned surgery during the trial.
•Have difficulty with venous blood collection, or subjects who faint at the sight of blood or a needle, or have difficulty with subcutaneous administration.