Human Immunodeficiency Virus-1 (HIV-1) InfectionPhase 1NCT05328583
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects
A Phase 1 study of Human Immunodeficiency Virus-1 (HIV-1) Infection, run by RetroLead (Shanghai) BioPharma Co., Ltd..
Trial summary
This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS5685 tablet in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus-1 (HIV-1) Infection
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2022to 10 Mar 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing to provide written informed consent and to comply with the study protocol;
- Must be 18 to 45 years of age (inclusive);
- Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 18 to 28 kg/m2 (inclusive);
- Physical examination, vital signs, laboratory tests, 12-lead ECG, eGFR (CKD-EPI formula), abdominal ultrasound and chest radiograph are normal or are judged not clinically significant by the investigator;
- Subjects (including partners) of childbearing potential are willing to useprotocol specified effective methods of contraception from screening to at least 8 months (for female) or 6 months (for male) after the final dose of study drug;
Who cannot join
- History or presence of any clinically significant cardiovascular, endocrine, neurological, gastrointestinal, respiratory, hematological, immunological, psychiatric, metabolic disorders or any diseases that may interfere with the study results;
- Subjects with severe infections, severe trauma or major surgical operation within 3 months before drug administration; or subjects plan to undergo surgery during the trial and within two weeks after the end of trial;
- Abnormal ECG that is clinically significant, or QTcF< 300 msec or >450 msec for men and >460 msec for women;
- Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
- Suspected allergy to any ingredient in the study drug;
- Use of any drug that inhibits or induces hepatic metabolism within 1 month prior to the first dose of study drug;
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- Any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug as judged by the investigator;
- Use of any prescription or over-the-counter medication, including herbal medications within 1 month prior to the first dose of study drug;
- Participation in clinical trials of any drug or medical device (except for screening failures) within 3 months before screening, or within 5 half-lives of the drug at screening (whichever is longer);
- Receiving vaccine(s) within 1 month prior to the first dose of study drug;
- Donation or loss of blood of ≥ 200 mL within 1 month or of ≥ 400 mL within 3 months prior to the first dose of study drug; or receiving blood transfusion within 8 weeks prior to the first dose of study drug; or have difficulty in venous blood collection, or whose physical condition cannot withstand intensive blood sampling;
- An average daily smoking of ≥ 5 cigarettes or an average daily alcohol intake of 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol liquor) within 3 months before screening;
- Subjects who cannot refrain from smoking and alcohol intake from 2 days before the start of study treatment until the last follow-up;
- Subjects who consume alcoholic beverages, Seville oranges, grapefruit or juices, or products containing caffeine or xanthine (such as coffee, tea, cola drinks and chocolate) from 2 days before the start of study treatment, and those who have special dietary requirements and cannot comply with the unified diet;
- Subjects with a history of drug abuse, drug dependence, or a positive drugs of abuse test, or a positive alcohol breath test before study drug administration;
- Pregnant or lactating females;
- Other conditions judged by the investigator to be not suitable to participate in the trial;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects
This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS5685 tablet in healthy subjects.
- Being tested
- HRS5685；Placebo
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS5685；PlaceboDrug
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H
Drug2: Placebo Single dose in group A-F and multiple doses in group G-H
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A（Part A） | Experimental | Drug1: HRS5685, dose 1; Drug2: Placebo Receives: Drug: HRS5685；Placebo |
| Treatment group B（Part A） | Experimental | Drug1: HRS5685, dose 2; Drug2: Placebo Receives: Drug: HRS5685；Placebo |
| Treatment group C（Part A） | Experimental | Drug1: HRS5685, dose 3; Drug2: Placebo Receives: Drug: HRS5685；Placebo |
| Treatment group D（Part A） | Experimental | Drug1: HRS5685, dose 4; Drug2: Placebo Receives: Drug: HRS5685；Placebo |
| Treatment group E（Part A） | Experimental | Drug1: HRS5685, dose 5; Drug2: Placebo Receives: Drug: HRS5685；Placebo |
| Treatment group F（Part A） | Experimental | Drug1: HRS5685, dose 6; Drug2: Placebo Receives: Drug: HRS5685；Placebo |
| Treatment group G（Part B） | Experimental | Drug1: HRS5685, dose 3; Drug2: Placebo Receives: Drug: HRS5685；Placebo |
| Treatment group H（Part B） | Experimental | Drug1: HRS5685, dose 4; Drug2: Placebo Receives: Drug: HRS5685；Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Incidence and severity of adverse events
Measured: Up to Day 63 after the last dose
Secondary outcomes (13)
Area under the concentration-time curve during a dosing interval (AUCtau),
Measured: Pre-dose up to Day 63 after the last dose
Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t)
Measured: Pre-dose up to Day 63 after the last dose
Area under the concentration-time curve extrapolated to infinity (AUC0-inf )
Measured: Pre-dose up to Day 63 after the last dose
Maximum observed concentration (Cmax)
Measured: Pre-dose up to Day 63 after the last dose
Time to Maximum observed concentration (Tmax)
Measured: Pre-dose up to Day 63 after the last dose
Half-life (t1/2),
Measured: Pre-dose up to Day 63 after the last dose
Apparent clearance (CL/F)
Measured: Pre-dose up to Day 63 after the last dose
Apparent volume of distribution (Vz/F)
Measured: Pre-dose up to Day 63 after the last dose
Trough concentration (Ctrough)
Measured: Pre-dose up to Day 63 after the last dose
Accumulation ratio (Rac),
Measured: Pre-dose up to Day 63 after the last dose
Renal clearance (CLr)
Measured: Pre-dose up to 72 hours post-dose
Cumulative amount of drug excreted (Ae)
Measured: Pre-dose up to 72 hours post-dose
Cumulative percentage of dose recovered (fe)
Measured: Pre-dose up to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start15 Apr 2022 (estimated)
- Primary completion10 Mar 2023 (estimated)
- Study completion10 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus-1 (HIV-1) InfectionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blinded, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RetroLead (Shanghai) BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328583
- Sponsor's protocol ID
- HRS5685-101
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05328583
- Acronym / sponsor ID
- HRS5685-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- RetroLead (Shanghai) BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 10 Mar 2023 (estimated)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 14 Apr 2022 (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 randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS5685 tablet in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
- Model description
- This is a randomized, double-blinded, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Treatment group A（Part A） | Experimental | Drug: HRS5685；PlaceboDrug1: HRS5685, dose 1; Drug2: Placebo |
| Treatment group B（Part A） | Experimental | Drug: HRS5685；PlaceboDrug1: HRS5685, dose 2; Drug2: Placebo |
| Treatment group C（Part A） | Experimental | Drug: HRS5685；PlaceboDrug1: HRS5685, dose 3; Drug2: Placebo |
| Treatment group D（Part A） | Experimental | Drug: HRS5685；PlaceboDrug1: HRS5685, dose 4; Drug2: Placebo |
| Treatment group E（Part A） | Experimental | Drug: HRS5685；PlaceboDrug1: HRS5685, dose 5; Drug2: Placebo |
| Treatment group F（Part A） | Experimental | Drug: HRS5685；PlaceboDrug1: HRS5685, dose 6; Drug2: Placebo |
| Treatment group G（Part B） | Experimental | Drug: HRS5685；PlaceboDrug1: HRS5685, dose 3; Drug2: Placebo |
| Treatment group H（Part B） | Experimental | Drug: HRS5685；PlaceboDrug1: HRS5685, dose 4; Drug2: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able and willing to provide written informed consent and to comply with the study protocol;
- Must be 18 to 45 years of age (inclusive);
- Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 18 to 28 kg/m2 (inclusive);
- Physical examination, vital signs, laboratory tests, 12-lead ECG, eGFR (CKD-EPI formula), abdominal ultrasound and chest radiograph are normal or are judged not clinically significant by the investigator;
- Subjects (including partners) of childbearing potential are willing to useprotocol specified effective methods of contraception from screening to at least 8 months (for female) or 6 months (for male) after the final dose of study drug;
Key exclusion criteria (17 listed)
- History or presence of any clinically significant cardiovascular, endocrine, neurological, gastrointestinal, respiratory, hematological, immunological, psychiatric, metabolic disorders or any diseases that may interfere with the study results;
- Subjects with severe infections, severe trauma or major surgical operation within 3 months before drug administration; or subjects plan to undergo surgery during the trial and within two weeks after the end of trial;
- Abnormal ECG that is clinically significant, or QTcF< 300 msec or >450 msec for men and >460 msec for women;
- Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
- Suspected allergy to any ingredient in the study drug;
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 |
|---|---|---|
| HRS5685；PlaceboDrug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H | Drug | Treatment group A（Part A）, Treatment group B（Part A）, Treatment group C（Part A）, Treatment group D（Part A）, Treatment group E（Part A）, Treatment group F（Part A）, Treatment group G（Part B）, Treatment group H（Part B） |
Primary outcome
Safety and tolerability: Incidence and severity of adverse events
Time frame: Up to Day 63 after the last dose
13 secondary outcomes
Area under the concentration-time curve during a dosing interval (AUCtau),
Time frame: Pre-dose up to Day 63 after the last dose
Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t)
Time frame: Pre-dose up to Day 63 after the last dose
Area under the concentration-time curve extrapolated to infinity (AUC0-inf )
Time frame: Pre-dose up to Day 63 after the last dose
Maximum observed concentration (Cmax)
Time frame: Pre-dose up to Day 63 after the last dose
Time to Maximum observed concentration (Tmax)
Time frame: Pre-dose up to Day 63 after the last dose
Half-life (t1/2),
Time frame: Pre-dose up to Day 63 after the last dose
Apparent clearance (CL/F)
Time frame: Pre-dose up to Day 63 after the last dose
Apparent volume of distribution (Vz/F)
Time frame: Pre-dose up to Day 63 after the last dose
Trough concentration (Ctrough)
Time frame: Pre-dose up to Day 63 after the last dose
Accumulation ratio (Rac),
Time frame: Pre-dose up to Day 63 after the last dose
Renal clearance (CLr)
Time frame: Pre-dose up to 72 hours post-dose
Cumulative amount of drug excreted (Ae)
Time frame: Pre-dose up to 72 hours post-dose
Cumulative percentage of dose recovered (fe)
Time frame: Pre-dose up to 72 hours post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Human Immunodeficiency Virus-1 (HIV-1) Infection, run by RetroLead (Shanghai) BioPharma Co., Ltd..
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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liping Ma (0518-82342973, liping.ma@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: Incidence and severity of adverse events (time frame: Up to Day 63 after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2022.