HealthyPhase 1NCT04527250
A Study of the Relative Bioavailability of ASC41 in Healthy Subjects
A Phase 1 study testing ASC41 in people with Healthy, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to compare the pharmacokinetic parameters of ASC41 in healthy subjects after single and multiple oral dosing. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ASC41
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2020to 30 Dec 2020
- 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
- 1. Age 18-45 (including boundary value). 2. Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).
- 3. She is of childbearing potential and is non-pregnant and willing to use adequate contraception from screening (within 30days from the first administration)until one month after the End of Study visit.
- 4. The pregnancy test of female subjects during the screening period is negative.
- 5. During the screening period, fasting low-density lipoprotein cholesterol (110mg/dl < fasting (LDL-C) < 190mg/ dL.
- 6. Those who voluntarily sign the informed consent.
Who cannot join
- 1. Patients with a history of thyroid disease or intolerance to beta blockers or abnormal thyroid function indicators during screening; 2. Previous history of fainting, fainting needle or fainting blood for unknown reasons.
- 3. Previous liver disease, or ALT, ASL and direct bilirubin in screening period exceed the normal range.
- 4. Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody are tested positive.
- 5. People who have taken special diet (including carambola, dragon fruit, mango, grapefruit, orange, etc.) or drunk alcohol, or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 2 weeks before taking the study drug.
- 6. Heavy smokers (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine;Smoking daily ≥ 5 sticks) and no smoking or alcohol prohibition during the study period.
- 7. Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.
Show all 9Show fewer
- 8. Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.
- 9. Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.
- 10. In addition to the above, the researchers judge that the participants are not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Pharmacokinetic Parameters of ASC41, a Randomized, Double-blind, Placebo-controlled in Healthy Subjects After Single and Multiple Doses
The objective of this study is to compare the pharmacokinetic parameters of ASC41 in healthy subjects after single and multiple oral dosing.
Read the detailed description
The purpose of this study was to evaluate the tolerability, safety pharmacokinetics and pharmacodynamic (biomarkers) of ASC41 tables in a randomized, double-blind, placebo-controlled single- and multiple-dose phase I clinical trial in healthy subjects the study. The effects of ASC41 on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) will be observed after repeated administration of ASC41 in healthy subjects.
- Conditions
- Healthy
- Being tested
- ASC41, ASC41 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC41Drug
ASC41,1mg/table;5mg/table
ASC41 placeboDrug
ASC41 placebo,1mg/table;5mg/table
| Study group | Role | What they receive |
|---|---|---|
| Experimental:1mg | Experimental | ASC41 one tablet (1mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27. Receives: Drug: ASC41 |
| Experimental:2mg | Experimental | ASC41 two tablets (2mg) single oral dose at Day 1 and two tablets daily for 14 days from Day 14 to Day 27. Receives: Drug: ASC41 |
| Experimental:5mg | Experimental | ASC41 one tablet (5mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27. Receives: Drug: ASC41 |
| Experimental:10mg | Experimental | ASC41 two tablets (10mg) single oral dose at Day 1. Receives: Drug: ASC41 |
| Experimental:20mg | Experimental | ASC41 four tablets (20mg) single oral dose at Day 1. Receives: Drug: ASC41 |
| Placebo:1mg | Placebo comparator | ASC41 placebo one tablet (1mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27. Receives: Drug: ASC41 placebo |
| Placebo:2mg | Placebo comparator | ASC41 placebo two tablets (2mg) single oral dose at Day 1 and two tablets daily for 14 days from Day 14 to Day 27. Receives: Drug: ASC41 placebo |
| Placebo:5mg | Placebo comparator | ASC41 placebo one tablet (5mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27. Receives: Drug: ASC41 placebo |
| Placebo:10mg | Placebo comparator | ASC41 placebo two tablets (10mg) single oral dose at Day 1. Receives: Drug: ASC41 placebo |
| Placebo:20mg | Placebo comparator | ASC41 placebo four tablets (20mg) single oral dose at Day 1. Receives: Drug: ASC41 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety and tolerability of ASC41 in healthy volunteers
Evaluation of the safety and tolerability of ASC41 in healthy volunteers
Measured: Up to 32 days
Secondary outcomes (6)
Cmax of ASC41
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
Tmax of ASC41
Evaluate the Time to reach the maximum plasma concentration after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
AUC of ASC41
Evaluate the Area under the plasma concentration versus time curve after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
t1/2 of ASC41
Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 administered to Chinese healthy volunteers volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
CL/F of ASC41
Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC41 administered to Chinese healthy volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
Vd/F of ASC41
Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC41 administered to Chinese healthy volunteers.
Measured: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start16 Sep 2020
- Primary completion18 Dec 2020
- Study completion30 Dec 2020
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.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527250
- Sponsor's protocol ID
- ASC-ASC41-I-CTP-02
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- 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 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Pharmacokinetic Parameters of ASC41, a Randomized, Double-blind, Placebo-controlled in Healthy Subjects After Single and Multiple Doses
- ClinicalTrials.gov ID
- NCT04527250
- Acronym / sponsor ID
- ASC-ASC41-I-CTP-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial People's Hospital
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 26 Aug 2020 (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 objective of this study is to compare the pharmacokinetic parameters of ASC41 in healthy subjects after single and multiple oral dosing.
Detailed description
The purpose of this study was to evaluate the tolerability, safety pharmacokinetics and pharmacodynamic (biomarkers) of ASC41 tables in a randomized, double-blind, placebo-controlled single- and multiple-dose phase I clinical trial in healthy subjects the study. The effects of ASC41 on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) will be observed after repeated administration of ASC41 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Experimental:1mg | Experimental | Drug: ASC41ASC41 one tablet (1mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27. |
| Experimental:2mg | Experimental | Drug: ASC41ASC41 two tablets (2mg) single oral dose at Day 1 and two tablets daily for 14 days from Day 14 to Day 27. |
| Experimental:5mg | Experimental | Drug: ASC41ASC41 one tablet (5mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27. |
| Experimental:10mg | Experimental | Drug: ASC41ASC41 two tablets (10mg) single oral dose at Day 1. |
| Experimental:20mg | Experimental | Drug: ASC41ASC41 four tablets (20mg) single oral dose at Day 1. |
| Placebo:1mg | Placebo comparator | Drug: ASC41 placeboASC41 placebo one tablet (1mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27. |
| Placebo:2mg | Placebo comparator | Drug: ASC41 placeboASC41 placebo two tablets (2mg) single oral dose at Day 1 and two tablets daily for 14 days from Day 14 to Day 27. |
| Placebo:5mg | Placebo comparator | Drug: ASC41 placeboASC41 placebo one tablet (5mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27. |
| Placebo:10mg | Placebo comparator | Drug: ASC41 placeboASC41 placebo two tablets (10mg) single oral dose at Day 1. |
| Placebo:20mg | Placebo comparator | Drug: ASC41 placeboASC41 placebo four tablets (20mg) single oral dose at Day 1. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Age 18-45 (including boundary value). 2. Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).
- 3. She is of childbearing potential and is non-pregnant and willing to use adequate contraception from screening (within 30days from the first administration)until one month after the End of Study visit.
- 4. The pregnancy test of female subjects during the screening period is negative.
- 5. During the screening period, fasting low-density lipoprotein cholesterol (110mg/dl < fasting (LDL-C) < 190mg/ dL.
- 6. Those who voluntarily sign the informed consent.
Key exclusion criteria (9 listed)
- 1. Patients with a history of thyroid disease or intolerance to beta blockers or abnormal thyroid function indicators during screening; 2. Previous history of fainting, fainting needle or fainting blood for unknown reasons.
- 3. Previous liver disease, or ALT, ASL and direct bilirubin in screening period exceed the normal range.
- 4. Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody are tested positive.
- 5. People who have taken special diet (including carambola, dragon fruit, mango, grapefruit, orange, etc.) or drunk alcohol, or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 2 weeks before taking the study drug.
- 6. Heavy smokers (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine;Smoking daily ≥ 5 sticks) and no smoking or alcohol prohibition during the study period.
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 |
|---|---|---|
| ASC41ASC41,1mg/table;5mg/table | Drug | Experimental:10mg, Experimental:1mg, Experimental:20mg, Experimental:2mg, Experimental:5mg |
| ASC41 placeboASC41 placebo,1mg/table;5mg/table | Drug | Placebo:10mg, Placebo:1mg, Placebo:20mg, Placebo:2mg, Placebo:5mg |
Primary outcome
Evaluation of the safety and tolerability of ASC41 in healthy volunteers
Time frame: Up to 32 days
Evaluation of the safety and tolerability of ASC41 in healthy volunteers
6 secondary outcomes
Cmax of ASC41
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
Tmax of ASC41
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
AUC of ASC41
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
t1/2 of ASC41
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
CL/F of ASC41
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
Vd/F of ASC41
Time frame: On Day 1,2,3,4 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 32 days.
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 20 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 ASC41 in people with Healthy, run by Ascletis Pharmaceuticals 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 5 inclusion and 9 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 20 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
Evaluation of the safety and tolerability of ASC41 in healthy volunteers (time frame: Up to 32 days). 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 20 Aug 2021.