HealthyPhase 1NCT03990688
A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects
A Phase 1 study testing AK3280 in people with Healthy, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in Sweden.
Trial summary
AK3280 is being developed to further improve the long-term efficacy and tolerability of treatment options for patients with fibrotic disorders.This study will evaluate the effect of AK3280 treatment on renal function and safety, and the PK of AK3280 compared with placebo 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
- Healthy
- What is being tested?
- AK3280
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- 3 Oct 2019to 21 Sep 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
- Willing and able to give full written informed consent for participation in the study.
- Healthy male or female subject aged 18-45 years inclusive.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2。
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator in agreement with the Medical Monitor.
- With normal renal function defined as mean plasma eGFR ≥80 mL/min/1.73 m2 at screening.
- Male subjects and applicable female subjects must agree to use effective contraceptive methods to prevent drug exposure of a partner and pregnancy.
Who cannot join
- History of allergy to iohexol or other contrast media, to iodine or to shellfish.
- History of any clinically significant disease or disorder or any other condition that in the opinion of the Investigator renders them unsuitable to participate in the study.
- Regular use of any prescribed or non-prescribed medication within two weeks prior to the (first) administration of IMP.
- Any significant elevation at screening or on Day -2 of liver or urinary or serum or plasma renal test results.
- Subjects with poor venous access.
- Subjects who have smoked cigarettes (including vapour cigarettes), cigars, and/or used nicotine-containing products within 3 months prior to their screening visit.
Show all 13Show fewer
- Positive screen for a drug of abuse or alcohol at screening or prior to administration of the IMP.
- Subjects who have not abstained from caffeine-containing beverages or products from at least 48 hours prior to screening.
- An abnormal diet within the 30 days prior to the first study drug dose.
- Any use of protein powders, xanthine and/or taurine containing energy drinks within 48 hours prior to screening.
- Blood donation (or corresponding blood loss) during the three months prior to screening.
- Employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Effect of Multiple Oral Doses of AK3280 on Renal Function in Healthy Subjects
AK3280 is being developed to further improve the long-term efficacy and tolerability of treatment options for patients with fibrotic disorders.This study will evaluate the effect of AK3280 treatment on renal function and safety, and the PK of AK3280 compared with placebo in healthy subjects.
- Conditions
- Healthy
- Being tested
- AK3280, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK3280Drug
Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral
PlaceboDrug
Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| AK3280 (Cohort 1) | Experimental | Subjects in Cohort 1 are administered with an oral dose of 100 mg AK3280 b.i.d from Day 1 to Day 14. Receives: Drug: AK3280 |
| AK3280 (Cohort 2) | Experimental | Subjects in Cohort 2 are orally administered with AK3280 q.d. or b.i.d from Day 1 to Day 14. The dose adjustment for Cohort 2 will be based on the emerging data from previous cohort. Receives: Drug: AK3280 |
| AK3280 (Cohort 3) | Experimental | Subjects in Cohort 3 are orally administered with AK3280 q.d. or b.i.d from Day 1 to Day 14. The dose adjustment for Cohort 3 will be based on the emerging data from previous cohorts. Receives: Drug: AK3280 |
| Placebo | Placebo comparator | For assessment of the Adverse Event (AE) profile, there are placebo controls in each dose cohort. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Directly measured absolute glomerular filtration rate (mGFR) results.
The effect of AK3280 treatment on GFR is measured by iohexol plasma clearance.
Measured: Days -1, 7, and 14.
Change from baseline mGFR results.
To compare the difference of effect of AK3280 treatment on GFR.
Measured: Days 7 and 14.
Secondary outcomes (8)
Frequency, intensity, and seriousness of Adverse Events (AEs)
An AE can be any unfavorable and unintended sign (including an abnormal safety laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Measured: From Day -1 to Day 28.
Change in blood renal function biomarkers
Blood renal function biomarkers include cystatin C, beta-trace protein, p-myoglobin, etc.
Measured: Screening, Days -2, 7, 14, and 21.
Change in urine renal function biomarkers
Urine renal function biomarkers include electrolytes, albumin, alpha1-microglobulin, etc.
Measured: From Day -1 to Day 21.
Maximum Observed Plasma Concentration (Cmax)
The maximum observed plasma concentration of AK3280 and its major metabolite, AK3280-M2.
Measured: Days 1, 7, and 14.
Concentration at the end of the dosing interval (Ctau)
The concentration of AK3280 and its major metabolite, AK3280-M2, at the end of the dosing interval.
Measured: Days 1, 7, and 14.
trough plasma concentration (Ctrough)
The trough observed plasma concentration of AK3280 and its major metabolite, AK3280-M2.
Measured: Days 1, 7 and 14.
trough plasma concentration (Ctrough)
The trough observed plasma concentration of AK3280 and its major metabolite, AK3280-M2.
Measured: Days 1, 7, and 14.
Area under the plasma concentration-time curve from time zero up to time (AUC 0-t)
The area under the plasma concentration-time curve from time zero up to the last analytically quantifiable concentration of AK3280.
Measured: Days 1, 7, and 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start3 Oct 2019
- Primary completion9 Sep 2020
- Study completion21 Sep 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jimmy Gu, Study director, info@arkbiosciences.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990688
- Sponsor's protocol ID
- AK3280-4001
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2019
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Effect of Multiple Oral Doses of AK3280 on Renal Function in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03990688
- Acronym / sponsor ID
- AK3280-4001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 19 Jun 2019 (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.
AK3280 is being developed to further improve the long-term efficacy and tolerability of treatment options for patients with fibrotic disorders.This study will evaluate the effect of AK3280 treatment on renal function and safety, and the PK of AK3280 compared with placebo in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AK3280 (Cohort 1) | Experimental | Drug: AK3280Subjects in Cohort 1 are administered with an oral dose of 100 mg AK3280 b.i.d from Day 1 to Day 14. |
| AK3280 (Cohort 2) | Experimental | Drug: AK3280Subjects in Cohort 2 are orally administered with AK3280 q.d. or b.i.d from Day 1 to Day 14. The dose adjustment for Cohort 2 will be based on the emerging data from previous cohort. |
| AK3280 (Cohort 3) | Experimental | Drug: AK3280Subjects in Cohort 3 are orally administered with AK3280 q.d. or b.i.d from Day 1 to Day 14. The dose adjustment for Cohort 3 will be based on the emerging data from previous cohorts. |
| Placebo | Placebo comparator | Drug: PlaceboFor assessment of the Adverse Event (AE) profile, there are placebo controls in each dose cohort. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing and able to give full written informed consent for participation in the study.
- Healthy male or female subject aged 18-45 years inclusive.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2。
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator in agreement with the Medical Monitor.
- With normal renal function defined as mean plasma eGFR ≥80 mL/min/1.73 m2 at screening.
Key exclusion criteria (13 listed)
- History of allergy to iohexol or other contrast media, to iodine or to shellfish.
- History of any clinically significant disease or disorder or any other condition that in the opinion of the Investigator renders them unsuitable to participate in the study.
- Regular use of any prescribed or non-prescribed medication within two weeks prior to the (first) administration of IMP.
- Any significant elevation at screening or on Day -2 of liver or urinary or serum or plasma renal test results.
- Subjects with poor venous access.
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 |
|---|---|---|
| AK3280Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral | Drug | AK3280 (Cohort 1), AK3280 (Cohort 2), AK3280 (Cohort 3) |
| PlaceboActive Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral | Drug | Placebo |
Primary outcome
Directly measured absolute glomerular filtration rate (mGFR) results.
Time frame: Days -1, 7, and 14.
The effect of AK3280 treatment on GFR is measured by iohexol plasma clearance.
Change from baseline mGFR results.
Time frame: Days 7 and 14.
To compare the difference of effect of AK3280 treatment on GFR.
8 secondary outcomes
Frequency, intensity, and seriousness of Adverse Events (AEs)
Time frame: From Day -1 to Day 28.
Change in blood renal function biomarkers
Time frame: Screening, Days -2, 7, 14, and 21.
Change in urine renal function biomarkers
Time frame: From Day -1 to Day 21.
Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1, 7, and 14.
Concentration at the end of the dosing interval (Ctau)
Time frame: Days 1, 7, and 14.
trough plasma concentration (Ctrough)
Time frame: Days 1, 7 and 14.
trough plasma concentration (Ctrough)
Time frame: Days 1, 7, and 14.
Area under the plasma concentration-time curve from time zero up to time (AUC 0-t)
Time frame: Days 1, 7, and 14.
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 9 Jun 2021.
- Individual participant dataSharing planned: No
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.
Jimmy Gu study director
info@arkbiosciences.com
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 AK3280 in people with Healthy, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in Sweden.
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 6 inclusion and 13 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 9 Jun 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 Sweden. 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?
Directly measured absolute glomerular filtration rate (mGFR) results. (time frame: Days -1, 7, and 14.). 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?
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 9 Jun 2021.