Single Ascending Dose Study of CM326 in Healthy Volunteers

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: CM326; Drug: Placebo

• Registration Number: NCT04842201
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study Start: 2021-04-13
• Study First Posted: 2021-04-13
• Primary Completion: 2021-09-28
• Study Completion: 2021-09-28
• Status Verified: 2021-11
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

Inclusion Criteria

• Healthy adult male participant,18 to 65 years of age, inclusive.
• Body Mass Index (BMI) 18 to 26 kg/m2, inclusive.
• History, physical examination, laboratory tests and test related items of inspection were normal or abnormal without clinically insignificant.
• Males must abstain from sex or use highly effective methods of birth control.
• Having given written informed consent prior to undertaking any study-related procedure.

Key

Exclusion Criteria

• Positive for HIV, or Hepatitis B, or C.
• Positive result on urine drug screen.
• Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
• With any condition that inappropriate for entry into this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CM326	CM326	subcutaneous injection
Placebo	Placebo	subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs	Day 1 through Day 85

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics of CM326	Day 1 through Day 85	Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time
Pharmacokinetics (PK) of CM326	Day 1 through Day 85	Serum concentrations of CM326 over time
Immunogenicity	Day 1 through Day 85	anti-drug antibody (ADA)

Trial Locations

Locations (1)

PKUCare Luzhong Hospital; 🇨🇳 Zibo, Shandong, China