Single Ascending Dose Study of CM326 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-13

Study Completion Date

2021-09-28

Brief Summary

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

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CM326

subcutaneous injection

Group Type EXPERIMENTAL

CM326

Intervention Type DRUG

subcutaneous injection

Placebo

subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

subcutaneous injection

Interventions

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CM326

subcutaneous injection

Intervention Type DRUG

Placebo

subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes