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Study of CM310 in Healthy Subjects

NCT ID: NCT06161090

Last Updated: 2023-12-07

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2020-01-13

Brief Summary

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This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 75 mg

CM310 Recombinant Humanized Monoclonal Antibody Injection

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310 injection

Group 150 mg

CM310 Recombinant Humanized Monoclonal Antibody Injection

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310 injection

Group 300 mg

CM310 Recombinant Humanized Monoclonal Antibody Injection

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310 injection

Group 600 mg

CM310 Recombinant Humanized Monoclonal Antibody Injection

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310 injection

Placebo

Placebo, Subcutaneous

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

subcutaneous injection

Interventions

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CM310

CM310 injection

Intervention Type BIOLOGICAL

Placebo

subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers.
* aged ≥ 18 and ≤ 65 years old.
* With all clinical laboratory examination normal.
* Voluntary signing of the informed consent form.

Exclusion Criteria

* With a history of asthma and allergic reactions.
* With a history of conjunctivitis and keratitis, as well as previous medical conditions.
* With positive results from alcohol breath or urine drug abuse testing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PKUCare Luzhong Hospital

Zibo, , China

Site Status

Countries

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China

References

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Zhang L, Zhang W, Xu Y, Dong L, Sun Y, Jia Y, Li Z, Chen B, Hou J, Zhang J. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis. Adv Ther. 2024 Jul;41(7):2953-2965. doi: 10.1007/s12325-024-02887-w. Epub 2024 Jun 4.

Reference Type DERIVED
PMID: 38833140 (View on PubMed)

Other Identifiers

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CM310HV001

Identifier Type: -

Identifier Source: org_study_id