Single Ascending Dose Study of CM326 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04842201

Enrollment

Registered

2021-04-13

Start date

2021-04-13

Completion date

2021-09-28

Last updated

2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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

Interventions

DRUGCM326

subcutaneous injection

DRUGPlacebo

subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026