Chronic Kidney Disease(CKD)Phase 1SK-08NCT07021157
A Study to Evaluate the Safety, Tolerability and PK of SK-08
A Phase 1 study testing SK-08 in people with Chronic Kidney Disease(CKD), run by Consun Pharmaceutical Group at 1 site in China.
Trial summary
The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease(CKD)
- What is being tested?
- SK-08
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2025to 7 Aug 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 male and female participants aged 18 to 45 years (inclusive).
- Male participants: Body weight ≥50 kg; Female participants: Body weight ≥45 kg; Body mass index (BMI) between 19.0 and 26 kg/m².
- Participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective contraception with no plans for sperm or egg donation .
- Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.
Who cannot join
- Have a specific history of allergies or have an allergic constitution；
- Have a history of chronic diseases or severe diseases in the cardiovascular, liver, kidney, biliary tract, respiratory, blood and lymphatic, endocrine, immune, mental, neuromuscular, gastrointestinal systems, etc.
- Developed acute diseases from 2 weeks before screening to before randomization ;
- Patients with previous or current hypotension or insufficient blood volume, intracranial hypertension or cerebral hemorrhage, or those with ocular diseases (such as angle-closure glaucoma), who are not suitable for inclusion after assessment by the researcher;
- Those with clinical significance hypokalemia, hyperkalemia, hypomagnesemia, hypermagnesemia, hypocalcemia, and hypercalcemia;
- Those who have used any drugs or health supplements from 2 weeks before screening to randomization ;
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- Any drugs that may interact with this product have been used from 30 days before screening to randomization, such as CYP450 inhibitors or inducers ;
- Those who have undergone major surgical operations from 6 months before screening , or who plan to undergo surgery during the study period, or who have undergone surgeries as judged by the investigator to affect drug absorption, distribution, metabolism, and excretion;
- Those who have received live attenuated vaccine inoculation from 2 weeks before screening to randomization or those who need to receive live attenuated vaccine inoculation during the trial;
- Those who had a history of alcohol abuse within one year before screening；
- Those who smoked more than 5 cigarettes per day on average within 3 months before screening and before randomization, or were unable to stop using any tobacco products during the trial period;
- Those who cannot tolerate venipuncture/indwelling needles or have a history of fainting from needles or blood ;
- Other researchers determined that the subjects were not suitable to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital，Zhejiang University
Hangzhou, Zhejiang, 310003
JIAN LIU, Master, 13958054006, lindaliu87@zju.edu.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Increasing of SK-08 Tablets in Healthy Participants
The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants.
Read the detailed description
The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants. Seven dose groups (A1 to A7) were preset. A total of 48 healthy subjects were planned to be enrolled.
- Conditions
- Chronic Kidney Disease(CKD)
- Being tested
- SK-08, Placebo
- Keywords
- Chronic Kidney Disease(CKD)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK-08Drug
Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given SK-08 once.
PlaceboDrug
Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given placebo once.
| Study group | Role | What they receive |
|---|---|---|
| SK-08 | Experimental | Seven sequential dose groups（A1-A7） will be evaluated: 5 mg, 7.5mg,12.5 mg, 20 mg, 30 mg, 45 mg, and 60 mg.
SK-08 were given once for 5mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg dose groups. Receives: Drug: SK-08 |
| Placebo | Placebo comparator | Seven sequential dose groups（A1-A7） will be evaluated: 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg.
Placebo were given once for 5mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg dose groups. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation
The occurrence of AE during the experiment
Measured: up to Day 12
Secondary outcomes (9)
PK Evaluation（Cmax）
Pharmacokinetic characteristics after administration (Cmax）
Measured: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PK Evaluation（Tmax）
Pharmacokinetic characteristics after administration
Measured: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PK Evaluation（ AUC0-T）
Pharmacokinetic characteristics after administration (AUC0-T）
Measured: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PK Evaluation ( AUC0-∞）
Pharmacokinetic characteristics after administration ( AUC0-∞）
Measured: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PD Evaluation（Heart rate）
Heart rate
Measured: within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing
PD Evaluation（blood pressure）
blood pressure
Measured: within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing
PD Evaluation（changes in cGMP concentration levels）
changes in cGMP concentration levels
Measured: within 1.00 hour pre-dosing and 0.50 hour, 1hour,1.5hour,2hour,2.5hour,3hour,4hour,5hour,6hour,8hour,12hour post-dosing
QT interval analysis indicators（QTcF）
QTcF
Measured: With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing
QT interval analysis indicators（ΔQTcF）
ΔQTcF
Measured: With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start9 Mar 2025
- Primary completion7 Aug 2025 (estimated)
- Study completion7 Aug 2025 (estimated)
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 Chronic Kidney Disease(CKD)Studies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consun Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021157
- Sponsor's protocol ID
- 2024-CP-SK08-01
- Acronym
- SK-08
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu J, Du Y, Zhou H, Jia H, Zhai Y, Ruan J, Yan C, Xu N, Xin Y, Zheng L, Song Y, Jiang D, Yang J. Safety, pharmacokinetic, and pharmacodynamic characteristics of SK-08, a soluble guanylate cyclase activator, after oral administration in healthy participants: a randomized phase 1 trial. BMC Nephrol. 2026 Jul 9. doi: 10.1186/s12882-026-05138-y. Online ahead of print.
PubMed 42426639
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Increasing of SK-08 Tablets in Healthy Participants
- ClinicalTrials.gov ID
- NCT07021157
- Acronym / sponsor ID
- SK-08 / 2024-CP-SK08-01
- Conditions
- Chronic Kidney Disease(CKD)
- Keywords
- Chronic Kidney Disease(CKD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Consun Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2025 (actual)
- Primary completion
- 7 Aug 2025 (estimated)
- Study completion
- 7 Aug 2025 (estimated)
- First posted
- 13 Jun 2025 (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 trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants.
Detailed description
The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants. Seven dose groups (A1 to A7) were preset. A total of 48 healthy subjects were planned to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SK-08 | Experimental | Drug: SK-08Seven sequential dose groups（A1-A7） will be evaluated: 5 mg, 7.5mg,12.5 mg, 20 mg, 30 mg, 45 mg, and 60 mg. SK-08 were given once for 5mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg dose groups. |
| Placebo | Placebo comparator | Drug: PlaceboSeven sequential dose groups（A1-A7） will be evaluated: 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg. Placebo were given once for 5mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg dose groups. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female participants aged 18 to 45 years (inclusive).
- Male participants: Body weight ≥50 kg; Female participants: Body weight ≥45 kg; Body mass index (BMI) between 19.0 and 26 kg/m².
- Participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective contraception with no plans for sperm or egg donation .
- Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.
Key exclusion criteria (13 listed)
- Have a specific history of allergies or have an allergic constitution；
- Have a history of chronic diseases or severe diseases in the cardiovascular, liver, kidney, biliary tract, respiratory, blood and lymphatic, endocrine, immune, mental, neuromuscular, gastrointestinal systems, etc.
- Developed acute diseases from 2 weeks before screening to before randomization ;
- Patients with previous or current hypotension or insufficient blood volume, intracranial hypertension or cerebral hemorrhage, or those with ocular diseases (such as angle-closure glaucoma), who are not suitable for inclusion after assessment by the researcher;
- Those with clinical significance hypokalemia, hyperkalemia, hypomagnesemia, hypermagnesemia, hypocalcemia, and hypercalcemia;
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 |
|---|---|---|
| SK-08Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given SK-08 once. | Drug | SK-08 |
| PlaceboDose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given placebo once. | Drug | Placebo |
Primary outcome
Safety Evaluation
Time frame: up to Day 12
The occurrence of AE during the experiment
9 secondary outcomes
PK Evaluation（Cmax）
Time frame: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PK Evaluation（Tmax）
Time frame: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PK Evaluation（ AUC0-T）
Time frame: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PK Evaluation ( AUC0-∞）
Time frame: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour，2.5 hour, 2.75hour，3 hour, 3.5hour，4 hour, 5hour，6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PD Evaluation（Heart rate）
Time frame: within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing
PD Evaluation（blood pressure）
Time frame: within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing
PD Evaluation（changes in cGMP concentration levels）
Time frame: within 1.00 hour pre-dosing and 0.50 hour, 1hour,1.5hour,2hour,2.5hour,3hour,4hour,5hour,6hour,8hour,12hour post-dosing
QT interval analysis indicators（QTcF）
Time frame: With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing
QT interval analysis indicators（ΔQTcF）
Time frame: With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Derived from this study: PubMed 42426639Liu J, Du Y, Zhou H, Jia H, Zhai Y, Ruan J, Yan C, Xu N, Xin Y, Zheng L, Song Y, Jiang D, Yang J. Safety, pharmacokinetic, and pharmacodynamic characteristics of SK-08, a soluble guanylate cyclase activator, after oral administration in healthy participants: a randomized phase 1 trial. BMC Nephrol. 2026 Jul 9. doi: 10.1186/s12882-026-05138-y. 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.
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 SK-08 in people with Chronic Kidney Disease(CKD), run by Consun Pharmaceutical Group 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 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JIAN LIU, Master (13958054006, lindaliu87@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation (time frame: up to Day 12). 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 NCT07021157, 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 24 Jun 2025.