HIV-1Phase 1NCT05944848
A Study of CL-197 Capsules in Healthy Participants
A Phase 1 study testing 1 mg CL-197 capsules in people with HIV-1, run by Henan Genuine Biotech Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of CL-197 capsules in health conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1
- What is being tested?
- 1 mg CL-197 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2022to 20 Jan 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subjects, aged 18~45 (including boundary values), both male and female;
- Body mass index (BMI) should be in the range of 19.0-26.0 (including the boundary value) (BMI = weight (kg) / height 2 (m2)), the body weight of male subjects should be ≥ 50.0kg, and the body weight of female subjects should be ≥ 45.0kg;
- Those who have no family plan within 2 weeks before screening and within 3 months after the end of the trial and agree to use effective non-pharmacological contraception during the trial;
- Understand and sign the informed consent form voluntarily.
Who cannot join
- Allergic constitution, with a history of drug or food allergies, especially allergic to any ingredient in this product and excipients;
- Those with a history of hypoglycemia in the past;
- Pre-test medical history, physical examination, laboratory items and test-related examinations and abnormal tests have clinical significance, and the clinical research doctor judges to be unqualified;
- Those with a history of smoking in the 12 months before screening (the number of cigarettes per day≥ 5);
- Those who have a history of alcoholism in the 12 months before screening (drink ≥ 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test (test value>0mg/100mL) before enrollment;
- Those who have a history of drug abuse within 12 months before screening or who have tested positive for addictive substances before enrollment;
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- Those who have undergone surgery within 3 months before screening, especially those who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion, or those who plan to undergo surgery during the study;
- Any drugs that interact with investigational drugs, such as potent CYP3A inhibitors (such as clarithromycin, indinavir, itraconazole, etc.), have been used within 30 days before screening;
- Have a previous history of cardiovascular, hepatic, renal, lung, digestive tract, nerve and other diseases, especially any surgical condition or condition that may affect the absorption, distribution, metabolism and excretion of drugs, or any surgical condition or condition that may pose a hazard to the subjects participating in the trial;
- Those who have a febrile illness within 3 days before screening;
- Those who have participated in other clinical trials within 3 months before screening;
- Those who have a history of taking any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health products within 14 days before screening;
- Those who consumed excessive tea, coffee and/or beverages rich in caffeine, xanthine and alcohol (more than 8 cups, 1 cup = 250mL) every day within 3 months before screening;
- Those who have lost blood or donated blood ≥ 200mL within 8 weeks before screening;
- Pregnant and lactating women;
- Those who cannot tolerate venipuncture blood collection and/or have a history of blood sickness and needle sickness;
- Those who have been vaccinated against the new coronavirus within 1 week before screening, or those who have received other vaccines within 3 months before screening;
- Those who are not considered suitable to enter this test by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality
About this study
Official title: A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of CL-197 Capsules Administered in Single Dose in Healthy Participants
The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of CL-197 capsules in health conditions.
Read the detailed description
In this trial, 46 healthy participants will be enrolled, 6 healthy participants in 1mg group, 40 healthy participants distributed equally in other four groups: 10mg group, 30mg group, 60mg group and 100mg group, including thier respective placebo control groups.
- Conditions
- HIV-1
- Being tested
- 1 mg CL-197 capsules, 10 mg CL-197 capsules or CL-197 placebo, 30 mg CL-197 capsules or CL-197 placebo, 60 mg CL-197 capsules or CL-197 placebo, 100 mg CL-197 capsules or CL-197 placebo
- Keywords
- HIV-1, AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mg CL-197 capsulesDrug
Single oral dose of 1 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
10 mg CL-197 capsules or CL-197 placeboDrug
Single oral dose of 10 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
30 mg CL-197 capsules or CL-197 placeboDrug
Single oral dose of 30 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
60 mg CL-197 capsules or CL-197 placeboDrug
Single oral dose of 60 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
100 mg CL-197 capsules or CL-197 placeboDrug
Single oral dose of 100 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
| Study group | Role | What they receive |
|---|---|---|
| 1mg group | Experimental | Single oral dose of 1 mg CL-197 capsules or CL-197 placebo Receives: Drug: 1 mg CL-197 capsules |
| 10mg group | Experimental | Single oral dose of 10 mg CL-197 capsules or CL-197 placebo Receives: Drug: 10 mg CL-197 capsules or CL-197 placebo |
| 30mg group | Experimental | Single oral dose of 30 mg CL-197 capsules or CL-197 placebo Receives: Drug: 30 mg CL-197 capsules or CL-197 placebo |
| 60mg group | Experimental | Single oral dose of 60 mg CL-197 capsules or CL-197 placebo Receives: Drug: 60 mg CL-197 capsules or CL-197 placebo |
| 100mg group | Experimental | Single oral dose of 100 mg CL-197 capsules or CL-197 placebo Receives: Drug: 100 mg CL-197 capsules or CL-197 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Safety and Tolerability of CL-197 Capsules ：Incidence of Treatment-Emergent Adverse Events as Assessed by The NCI CTCAE V5.0 Grading Criteria
The degree of adverse events observed in the trial would be determined by the NCI CTCAE v5.0 grading criteria, and the adverse events related to the test drug (definitely related, likely to be related, and possibly related) would be terminated in the following cases, and the previous dose would be used as the MTD of the single-dose tolerance test.
Measured: Up to 29 days post-dose
Secondary outcomes (4)
The Peak Plasma Concentration (Cmax) of CL-197 Capsules
The index components in human blood samples would be measured by LC-MS/MS, and the peak plasma concentration (Cmax) would be calculated.
Measured: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Area Under the Plasma Concentration Versus Time Curve (AUC) of CL-197 Capsules
The index components in human blood samples would be measured by LC-MS/MS, and the area under the plasma concentration versus time curve (AUC) would be calculated.
Measured: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Elimination Half-Life (t1/2) of CL-197 Capsules
The index components in human blood samples would be measured by LC-MS/MS, and the elimination half-life (t1/2) would be calculated.
Measured: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Accumulate Urinary Drug Excretion (Ae) of CL-197 Capsules
The index components in human urine samples would be measured by LC-MS/MS, and the accumulate urinary drug excretion (Ae) would be calculated.
Measured: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start16 Nov 2022
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1Studies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wang Fusheng, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944848
- Sponsor's protocol ID
- CR-CL-197-101
- Status last verified
- Apr 2024
- First submitted
- 3 Jul 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo Y, Li Y, Zhao P, Bi J, Gou C, Chuai Z, Yu S, Zhang R, Du J, Ou Y, Xu R, Guo N, Wang F-S, Li Y. Safety and pharmacokinetics of CL-197, a potent compound with low cytotoxicity against HIV-1: a randomized, double-blind, placebo-controlled, first-in-human phase 1 clinical trial. Antimicrob Agents Chemother. 2026 Sep 4:e0098426. doi: 10.1128/aac.00984-26. Online ahead of print.
PubMed 42695945
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of CL-197 Capsules Administered in Single Dose in Healthy Participants
- ClinicalTrials.gov ID
- NCT05944848
- Acronym / sponsor ID
- CR-CL-197-101
- Conditions
- HIV-1
- Keywords
- HIV-1, AIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 13 Jul 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.
The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of CL-197 capsules in health conditions.
Detailed description
In this trial, 46 healthy participants will be enrolled, 6 healthy participants in 1mg group, 40 healthy participants distributed equally in other four groups: 10mg group, 30mg group, 60mg group and 100mg group, including thier respective placebo control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1mg group | Experimental | Drug: 1 mg CL-197 capsulesSingle oral dose of 1 mg CL-197 capsules or CL-197 placebo |
| 10mg group | Experimental | Drug: 10 mg CL-197 capsules or CL-197 placeboSingle oral dose of 10 mg CL-197 capsules or CL-197 placebo |
| 30mg group | Experimental | Drug: 30 mg CL-197 capsules or CL-197 placeboSingle oral dose of 30 mg CL-197 capsules or CL-197 placebo |
| 60mg group | Experimental | Drug: 60 mg CL-197 capsules or CL-197 placeboSingle oral dose of 60 mg CL-197 capsules or CL-197 placebo |
| 100mg group | Experimental | Drug: 100 mg CL-197 capsules or CL-197 placeboSingle oral dose of 100 mg CL-197 capsules or CL-197 placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult subjects, aged 18~45 (including boundary values), both male and female;
- Body mass index (BMI) should be in the range of 19.0-26.0 (including the boundary value) (BMI = weight (kg) / height 2 (m2)), the body weight of male subjects should be ≥ 50.0kg, and the body weight of female subjects should be ≥ 45.0kg;
- Those who have no family plan within 2 weeks before screening and within 3 months after the end of the trial and agree to use effective non-pharmacological contraception during the trial;
- Understand and sign the informed consent form voluntarily.
Key exclusion criteria (18 listed)
- Allergic constitution, with a history of drug or food allergies, especially allergic to any ingredient in this product and excipients;
- Those with a history of hypoglycemia in the past;
- Pre-test medical history, physical examination, laboratory items and test-related examinations and abnormal tests have clinical significance, and the clinical research doctor judges to be unqualified;
- Those with a history of smoking in the 12 months before screening (the number of cigarettes per day≥ 5);
- Those who have a history of alcoholism in the 12 months before screening (drink ≥ 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test (test value>0mg/100mL) before enrollment;
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 |
|---|---|---|
| 1 mg CL-197 capsulesSingle oral dose of 1 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast | Drug | 1mg group |
| 10 mg CL-197 capsules or CL-197 placeboSingle oral dose of 10 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast | Drug | 10mg group |
| 30 mg CL-197 capsules or CL-197 placeboSingle oral dose of 30 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast | Drug | 30mg group |
| 60 mg CL-197 capsules or CL-197 placeboSingle oral dose of 60 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast | Drug | 60mg group |
| 100 mg CL-197 capsules or CL-197 placeboSingle oral dose of 100 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast | Drug | 100mg group |
Primary outcome
The Safety and Tolerability of CL-197 Capsules ：Incidence of Treatment-Emergent Adverse Events as Assessed by The NCI CTCAE V5.0 Grading Criteria
Time frame: Up to 29 days post-dose
The degree of adverse events observed in the trial would be determined by the NCI CTCAE v5.0 grading criteria, and the adverse events related to the test drug (definitely related, likely to be related, and possibly related) would be terminated in the following cases, and the previous dose would be used as the MTD of the single-dose tolerance test.
4 secondary outcomes
The Peak Plasma Concentration (Cmax) of CL-197 Capsules
Time frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Area Under the Plasma Concentration Versus Time Curve (AUC) of CL-197 Capsules
Time frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Elimination Half-Life (t1/2) of CL-197 Capsules
Time frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Accumulate Urinary Drug Excretion (Ae) of CL-197 Capsules
Time frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
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 25 Apr 2024.
- Derived from this study: PubMed 42695945Guo Y, Li Y, Zhao P, Bi J, Gou C, Chuai Z, Yu S, Zhang R, Du J, Ou Y, Xu R, Guo N, Wang F-S, Li Y. Safety and pharmacokinetics of CL-197, a potent compound with low cytotoxicity against HIV-1: a randomized, double-blind, placebo-controlled, first-in-human phase 1 clinical trial. Antimicrob Agents Chemother. 2026 Sep 4:e0098426. doi: 10.1128/aac.00984-26. Online ahead of print.
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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.
Wang Fusheng principal investigator
Medical Director
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 1 mg CL-197 capsules in people with HIV-1, run by Henan Genuine Biotech 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 18 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 25 Apr 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?
The Safety and Tolerability of CL-197 Capsules ：Incidence of Treatment-Emergent Adverse Events as Assessed by The NCI CTCAE V5.0 Grading Criteria (time frame: Up to 29 days post-dose). 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 NCT05944848, which also lists 1 linked publication.
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 25 Apr 2024.