HealthyPhase 1NCT05702450

Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

A Phase 1 study testing CM310 in people with Healthy, run by Keymed Biosciences Co.Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: CM310
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteChina
Study dates: 22 Mar 2023to 26 Jul 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Have the ability to understand the study.
Voluntarily participate in the study and sign the ICF.
18 years ≤ age ≤ 65 years, male and female.
Willing to take effective contraceptive measures during the study period.

Who cannot join

Plan to receive any major surgery during the study period.
With malignant tumors within 5 years before screening.
Positive results of alcohol breath test or urine drug abuse screening during screening period.
Any reason that the investigator believes that will prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

PKUCare Luzhong Hospital
Zibo

Other trials in China

About this study

Official title: A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.

Read the detailed description

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

Conditions: Healthy
Being tested: CM310

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CM310Biological
CM310 Recombinant Humanized Monoclonal Antibody Injection

Study groups in NCT05702450
Study group	Role	What they receive
Group P1	Experimental	CM310, Subcutaneous Receives: Biological: CM310
Group P2	Active comparator	CM310, Subcutaneous, as the parallel control group Receives: Biological: CM310

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic: the maximum concentration (Cmax)
Concentration and exposure
Measured: up to 57 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 202326 Jul 2023

First posted27 Jan 2023
Study start22 Mar 2023
Primary completion26 Jul 2023
Study completion26 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Keymed Biosciences Co.LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05702450
Sponsor's protocol ID: CM310-100002
Status last verified: Jan 2023
First submitted: 12 Jan 2023
Last updated: 15 Oct 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
ClinicalTrials.gov ID: NCT05702450
Acronym / sponsor ID: CM310-100002
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
Study start: 22 Mar 2023 (actual)
Primary completion: 26 Jul 2023 (actual)
Study completion: 26 Jul 2023 (actual)
First posted: 27 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group P1	Experimental	Biological: CM310CM310, Subcutaneous
Group P2	Active comparator	Biological: CM310CM310, Subcutaneous, as the parallel control group

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have the ability to understand the study.
Voluntarily participate in the study and sign the ICF.
18 years ≤ age ≤ 65 years, male and female.
Willing to take effective contraceptive measures during the study period.

Key exclusion criteria (4 listed)

Plan to receive any major surgery during the study period.
With malignant tumors within 5 years before screening.
Positive results of alcohol breath test or urine drug abuse screening during screening period.
Any reason that the investigator believes that will prevent the subject from participating in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CM310CM310 Recombinant Humanized Monoclonal Antibody Injection	Biological	Group P1, Group P2

Primary outcome

Pharmacokinetic: the maximum concentration (Cmax)
Time frame: up to 57 days
Concentration and exposure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
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Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jie Hou principal investigator

Peking University Care Luzhong Hospital

Hong Wang principal investigator

Peking University Care Luzhong Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CM310 in people with Healthy, run by Keymed Biosciences Co.Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic: the maximum concentration (Cmax) (time frame: up to 57 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05702450.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.