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Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects

NCT ID: NCT06171048

Last Updated: 2023-12-14

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-04-30

Brief Summary

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This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.

Detailed Description

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This study includes screening and treatment and follow-up periods.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

CM310 injection, Subcutaneous

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310 injection

Group B

CM310 injection, Subcutaneous

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310 injection

Interventions

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CM310

CM310 injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 20 years ≤ age ≤ 45 years.
* Voluntarily participate in the study and sign the ICF.
* Have the ability to understand the study.

Exclusion Criteria

* With history of chronic or serious illness.
* With any medication within 28 days prior to administration;
* Plan to undergo surgery during the research period;
* With any situations unsuitable to participate in this study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 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

Principal Investigators

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Wei Hu

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medical University

Locations

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The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Countries

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China

Central Contacts

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Qian Jia

Role: CONTACT

Phone: 028-88610620

Email: [email protected]

Facility Contacts

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Wei Hu

Role: primary

Other Identifiers

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CM310-100005

Identifier Type: -

Identifier Source: org_study_id