Single Ascending Dose Study of CM326 in Healthy Volunteers

Asthma Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CM326 in Adult Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842201
• Other study ID #: CM326HV001
• Status: Completed
• Phase: Phase 1
• Start date: April 13, 2021
• Est. completion date: September 28, 2021

Study information

• Verified date: November 2021
• Source: Keymed Biosciences Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 28, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Key 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CM326
subcutaneous injection
• Placebo
subcutaneous injection

Locations

Country	Name	City	State
China	PKUCare Luzhong Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK) of CM326	Serum concentrations of CM326 over time	Day 1 through Day 85
Secondary	Pharmacodynamics of CM326	Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time	Day 1 through Day 85
Secondary	Immunogenicity	anti-drug antibody (ADA)	Day 1 through Day 85