AzTrials
AzTrials

Healthy Male SubjectsPhase 1NCT05792917

Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers

A Phase 1 study testing tafolecimab (a modified manufacturing process) and tafolecimab (a original manufacturing process) in people with Healthy Male Subjects, run by Innovent Biologics (Suzhou) 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.

Official record
Search all trials

Trial summary

This trial is conducted in China. The purpose of this study is to evaluate the pharmacokinetic similarity of Tafolecimab with different manufacturing process in healthy male subjects. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Male Subjects
What is being tested?
tafolecimab (a modified manufacturing process) and tafolecimab (a original manufacturing process)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
1 siteChina
Study dates
6 Mar 2023to 4 Aug 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
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male subjects between 18 and 65 years of age, inclusive.
  • Low-density lipoprotein cholesterol (LDL-C) within the range of 1.8 mmol/L to 4.9 mmol/L, inclusive, at screening.
  • Body weight within the range of 63.0 kilograms (kg) to 75.0 kg, inclusive.
  • Subjects who are willing maintain current normal diet and physical activity.
  • Subjects agree to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, injectable contraceptive medroxyprogesterone or subcutaneous implant contraception, etc.) during the study period and within 6 months after the study drug infusion.
  • No history of serious diseases, including (but not limited to) cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurologic, endocrine, pulmonary, hematological, immune disease.
  • Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol.

Who cannot join

  • Subjects who have a history of allergy, or may be allergic to the investigational drug and the related compounds.
  • Have used the inhibitors of proprotein convertase subtilisin type 9 (PCSK-9).
  • Have clinically relevant abnormalities identified by Vital signs, physical examination, clinical laboratory tests, 12-lead ECG, or chest X-ray, at screening.
  • Unwilling to stop any strenuous physical activity (such as weightlifting or long-distance running) within 72 hours before the planned follow-up visit.
  • History of hospitalization within 1 month before screening, major surgery within 6 months before screening, or other unstable conditions judged by the investigator.
  • The last dose of the previous investigational product which is chemical drug has been given in less than 1 month before administration.
Show all 15Show fewer
  • The last dose of the previous investigational product which is biological drug has been given in less than 3 months before administration.
  • Have used any drugs (including over-the-counter drugs or prescription drugs), the last medication is less than 14 days or the last medication is less than 5 half-lives of the drug from the administration day (whichever is longer), or are using any drugs.
  • Have used any traditional Chinese medicines, vitamins or drugs or supplements known to affect lipid metabolism within 30 days before administration.
  • Have a positive test result of human immunodeficiency virus (Human Immunodeficiency Virus, HIV) antibody, hepatitis B virus surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or syphilis test at screening.
  • History of alcohol or drug abuse results within 12 months before screening. Average daily alcohol intake is more than 3 units of alcohol (male) (1 unit≈360mL beer, or 45mL spirits with 40% alcohol content, or 150mL wine), or unwilling to stop drinking 72 hours before administration and throughout the study period, or a positive ethanol breath test at screening, or positive drug screening results by urine at screening.
  • unable to abstain from smoking, alcohol and caffeinated beverages within 72 hours before administration and throughout the study period.
  • lost blood, donated blood ≥200 ml within 2 months before screening.
  • History of organ transplantation or malignant tumor.
  • Not suitable for this study in the investigator's opinion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Aerospace Center Hospital

    Beijing

Other trials in China

About this study

Official title: Bioequivalence Study of Tafolecimab Injections Manufactured by Two Different Processes in Chinese Healthy Male Volunteers

This trial is conducted in China. The purpose of this study is to evaluate the pharmacokinetic similarity of Tafolecimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process,also to determine Pharmacodynamics of Tafolecimab with different manufacturing process

Being tested
tafolecimab (a modified manufacturing process), tafolecimab (a original manufacturing process)

What participants receive

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

  • tafolecimab (a modified manufacturing process)Drug

    Also called IBI306 (a modified manufacturing process)

    450mg，SC，single dose

  • tafolecimab (a original manufacturing process)Drug

    Also called IBI306 (a original manufacturing process)

    450mg，SC，single dose

Study groups in NCT05792917
Study groupRoleWhat they receive
tafolecimab (a modified manufacturing process)Experimental450mg，SC，single dose
Receives: Drug: tafolecimab (a modified manufacturing process)
tafolecimab (a original manufacturing process)Active comparator450mg，SC，single dose
Receives: Drug: tafolecimab (a original manufacturing process)

What is being measured

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

  1. Bioequivalence results using the peak serum drug concentration (Cmax) as the judging indicators

    Measured: up to Day 57

  2. Bioequivalence results using the area under the serum concentration-time curve (AUC0-inf) as the judging indicators

    Measured: up to Day 57

Secondary outcomes (8)

  1. Other PK parameters: Area under the plasma concentration-time curve (AUClast)

    Measured: up to Day 57

  2. Other PK parameters: Volume of distribution (V)

    Measured: up to Day 57

  3. Other PK parameters: elimination half-life (t1/2)

    Measured: up to Day 57

  4. Number of participants with adverse events, with abnormal vital signs, abnormal physical examination, abnormal laboratory test results and abnormal ECG readings

    Measured: up to Day 57

  5. The occurrence of Anti-drug Antibody(ADA)

    Measured: up to Day 57

  6. The occurrence of Neutralizing antibodies Antibody(NAb)

    Measured: up to Day 57

  7. Percentage Change from baseline in Low Density Lipoprotein choleterol (LDL-C)

    Measured: up to Day 57

  8. Percentage Change from baseline in Proprotein convertase subtilisin/kexin type 9(PCSK-9)

    Measured: up to Day 57

Timeline

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

  1. First posted31 Mar 2023
  2. Study start6 Mar 2023
  3. Primary completion26 Mar 2023
  4. Study completion4 Aug 2023

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05792917
Sponsor's protocol ID
CIBI306K101
Status last verified
Apr 2023
First submitted
6 Mar 2023
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tafolecimab (a modified manufacturing process) and tafolecimab (a original manufacturing process) in people with Healthy Male Subjects, run by Innovent Biologics (Suzhou) 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 7 inclusion and 15 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 13 Sep 2023. 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?

Bioequivalence results using the peak serum drug concentration (Cmax) as the judging indicators (time frame: up to Day 57). The study lists 2 primary outcomes in all. 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 NCT05792917.

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 13 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in