HealthyPhase 1NCT04036227

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248

A Phase 1 study testing GS-248 in people with Healthy, run by Gesynta Pharma AB at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a First in Human (FIH), double-blinded, parallel-group, randomised, placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single and multiple ascending oral doses of GS-248 in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: GS-248
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteSweden
Study dates: 3 Jul 2019to 20 Dec 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Willing and able to give written informed consent for participation in the study.
Male and female healthy subjects aged 18-70 years inclusive (Part I [SAD]) and 40-75 years inclusive (Part II [MAD])
Women of child bearing potential must practice abstinence or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy from at least 4 weeks prior to dose to 4 weeks after last dose. Their male partner must agree to use a condom during the same time frame. Women of non-childbearing potential are defined as pre-menopausal females who are sterilised or post-menopausal defined as 12 months of amenorrhea.
Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above).
Body mass index (BMI) ≥ 19 and ≤ 30 kg/m2.
Subjects must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator.

Who cannot join

Known allergy to any components of the GS-248 formulation.
Females who are breast feeding or plan to be pregnant.
Positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening and within 24 h prior to the first administration of Investigational Medicinal Product (IMP).
Use of corticosteroids (inhaled and systemic), NSAIDs (including e.g. coxibs and aspirin), antacids, Proton pump inhibitors (PPIs) or any medication that changes gastric pH within 2 weeks prior to the (first) administration of IMP.
Regular use of any prescribed or non-prescribed medication including analgesics, herbal remedies, vitamins and minerals within 2 weeks prior to the (first) administration of IMP, except hormonal contraception and occasional intake of paracetamol (maximum 2000 mg/day; and not exceeding 3000 mg/week) and nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
Inherited or acquired disorders of platelet function, bleeding or coagulation.

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Presence of any clinically relevant acute or chronic disease that could interfere with the subject's safety during the clinical study or expose the subject to undue risk.
After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
Systolic blood pressure <90 or >140 mmHg, or
Diastolic blood pressure <50 or >90 mmHg, or
Pulse <40 or >90 bpm
Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.
Presence or history of drug and/or alcohol abuse and/or excessive intake of alcohol and/or history, or current use, of anabolic steroids, as judged by the Investigator.
Any positive result for drug abuse and/or alcohol at screening or on admission to the unit prior to administration of the IMP.
Participation in another clinical study with an experimental drug within 3 months before the administration of IMP.
Consumption of grapefruit or grapefruit juice within 14 days of study drug administration.
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
Any planned major surgery within the duration of the study.
Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than 3 times per week is allowed before screening visit.
Regular excessive caffeine consumption defined by a daily intake of >5 cups of caffeine containing beverages.
Intake of xanthine and/or taurine containing energy drinks within 2 days prior to screening.
Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

CTC Clinical Trial Consultants AB
Uppsala, SE-75237

Other trials in Sweden

About this study

Official title: A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)

Read the detailed description

Part I (SAD); In the SAD part of the study, single oral doses of GS-248 will be administered in 6 sequential cohorts, each consisting of 8 subjects randomised to receive either GS 248 or placebo in a 3:1 ratio. The first 2 subjects in each cohort will be dosed in a sentinel fashion; 1 subject will receive GS-248 and the other will receive placebo as randomised. The subjects will be carefully monitored by clinical staff during and after dosing. Vital signs, safety laboratory and ECG will be checked at regular intervals.

Part II (MAD); The MAD part of the study will explore multiple ascending dosing of GS-248 administered for 10 days. The proposed starting dose is 25 mg/day. However, the starting dose as well as subsequent dose levels may be adjusted based on safety and PK evaluation in previous cohorts. GS-248 will be administered in 4 sequential cohorts, each of 8 subjects randomised to receive either GS 248 or placebo in a 3:1 ratio. The subjects will be carefully monitored by clinical staff during and after dosing. Vital signs, safety laboratory and ECG will be checked at regular intervals.

Conditions: Healthy
Being tested: GS-248, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GS-248Drug
GS-248 oral solution
PlaceboDrug
Placebo oral solution with the same composition to match active drug

Study groups in NCT04036227
Study group	Role	What they receive
GS-248	Experimental	Part I (SAD): Single doses of 1 mg, 5 mg, 25 mg, 75 mg, 225 mg and 450 mg (planned doses) Part II (MAD): Multiple ascending doses for 10 days in four cohorts with planned doses of 25 mg, 75 mg, 225 mg and 450 mg. The doses will be finally selected based on results from Part I. Receives: Drug: GS-248
Placebo	Placebo comparator	Matching placebo oral solution Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Treatment Related Adverse Events
AEs were assessed as 'unlikely', 'possibly' or 'probably' related to the IMP. 'Possibly' and 'probably' were categorized as treatment related.
Measured: AEs were collected from the start of IMP administration until the end-of-study visit of each part, an average of 10 days in Part 1 (SAD) and 20 days in Part 2 (MAD).
Clinically Significant Changes in ECG
Single 12-lead ECG was recorded in supine position after 10 minutes of rest using an ECG machine. Heart rate and PQ/PR, QRS, QT and QTcF intervals were recorded. Ambulatory ECG telemetry was used for cardiac surveillance up to 24 h after IMP administration in the SAD part of the study.
Measured: 12-lead ECG was measured at pre-defined timepoints from the screening visit until the end-of-study visit, an average of 10 days in Part I (SAD) and 20 days in Part II (MAD).
Clinically Significant Changes in Vital Signs
Systolic and diastolic blood pressure and pulse were measured in supine position after 10 minutes of rest. Body temperature was measured orally using a digital thermometer.
Measured: Vital signs was checked at pre-defined timepoints from the screening visit until the end-of-study visit, an average of 10 days in Part 1 (SAD) and 20 days in Part 2 (MAD).
Clinically Significant Changes in Safety Laboratory Parameters
Blood samples for analysis of clinical chemistry, haematology and coagulation parameters.
Measured: Blood samples were collected at pre-defined timepoints from the screening visit until the end-of-study visit, an average of 10 days in Part I (SAD) and 20 days in Part II (MAD).
Clinically Significant Changes in Physical Examination
A complete physical examination included assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities.
Measured: Physical examination was performed at pre-defined timepoints from the screening visit until the end-of- study visit, an average of 10 days in Part I (SAD) and 20 days in Part II (MAD).

Secondary outcomes (9)

Cmax:
Maximum plasma concentration.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose; MAD Day 1-3 (first dose) and Day 10-12 (last dose): pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
Tmax:
Time to Cmax.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose; MAD: Day 1-3 (first dose) Day 10-12 (last dose): pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
T½:
Terminal elimination half-life
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose); MAD: Day 1-3 and Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
AUC0-t:
Area under the concentration time curve from the time of dosing to the time of the last observation.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose); MAD: Day 1-3 and Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
AUC 0-inf
Area under the curve from time 0 to infinity.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose
AUCss
Area under the plasma concentration curve during a dosing interval at steady state.
Measured: MAD: Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
Clearance (CL)/F:
Apparent total body clearance following extravascular administration.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose); MAD Day 1-3 and Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
Vz/F:
Apparent volume of distribution following extravascular administration
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose); MAD: Day 1-3 and Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
Accumulation Ratio AUC 0-ss
Measured: MAD: Day 1-3 and Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 201920 Dec 2019

First posted29 Jul 2019
Study start3 Jul 2019
Primary completion20 Dec 2019
Study completion20 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Model description: Part I (SAD) Within each cohort, subjects will be randomised in a 3:1 ratio to receive either GS 248 (n=6) or placebo (n=2) in a blinded fashion. Part II (MAD) Within each cohort, subjects will be randomised in a 3:1 ratio to receive GS-248 (n=6) or placebo (n=2) in a blinded fashion.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04036227
Sponsor's protocol ID: GS-1001
Status last verified: May 2022
First submitted: 23 Jul 2019
Last updated: 11 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)
ClinicalTrials.gov ID: NCT04036227
Acronym / sponsor ID: GS-1001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Gesynta Pharma ABIndustry (pharma, biotech, devices)
Collaborators: CTC Clinical Trial Consultants AB
Study start: 3 Jul 2019 (actual)
Primary completion: 20 Dec 2019 (actual)
Study completion: 20 Dec 2019 (actual)
First posted: 29 Jul 2019 (actual)
Results: Posted 8 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Part I (SAD) Within each cohort, subjects will be randomised in a 3:1 ratio to receive either GS 248 (n=6) or placebo (n=2) in a blinded fashion. Part II (MAD) Within each cohort, subjects will be randomised in a 3:1 ratio to receive GS-248 (n=6) or placebo (n=2) in a blinded fashion.

Arm	Type	Receives
GS-248	Experimental	Drug: GS-248Part I (SAD): Single doses of 1 mg, 5 mg, 25 mg, 75 mg, 225 mg and 450 mg (planned doses) Part II (MAD): Multiple ascending doses for 10 days in four cohorts with planned doses of 25 mg, 75 mg, 225 mg and 450 mg. The doses will be finally selected based on results from Part I.
Placebo	Placebo comparator	Drug: PlaceboMatching placebo oral solution

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Willing and able to give written informed consent for participation in the study.
Male and female healthy subjects aged 18-70 years inclusive (Part I [SAD]) and 40-75 years inclusive (Part II [MAD])
Women of child bearing potential must practice abstinence or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy from at least 4 weeks prior to dose to 4 weeks after last dose. Their male partner must agree to use a condom during the same time frame. Women of non-childbearing potential are defined as pre-menopausal females who are sterilised or post-menopausal defined as 12 months of amenorrhea.
Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above).
Body mass index (BMI) ≥ 19 and ≤ 30 kg/m2.

Key exclusion criteria (25 listed)

Known allergy to any components of the GS-248 formulation.
Females who are breast feeding or plan to be pregnant.
Positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening and within 24 h prior to the first administration of Investigational Medicinal Product (IMP).
Use of corticosteroids (inhaled and systemic), NSAIDs (including e.g. coxibs and aspirin), antacids, Proton pump inhibitors (PPIs) or any medication that changes gastric pH within 2 weeks prior to the (first) administration of IMP.
Regular use of any prescribed or non-prescribed medication including analgesics, herbal remedies, vitamins and minerals within 2 weeks prior to the (first) administration of IMP, except hormonal contraception and occasional intake of paracetamol (maximum 2000 mg/day; and not exceeding 3000 mg/week) and nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.

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
GS-248GS-248 oral solution	Drug	GS-248
PlaceboPlacebo oral solution with the same composition to match active drug	Drug	Placebo

Primary outcome

Number of Treatment Related Adverse Events
Time frame: AEs were collected from the start of IMP administration until the end-of-study visit of each part, an average of 10 days in Part 1 (SAD) and 20 days in Part 2 (MAD).
AEs were assessed as 'unlikely', 'possibly' or 'probably' related to the IMP. 'Possibly' and 'probably' were categorized as treatment related.
Clinically Significant Changes in ECG
Time frame: 12-lead ECG was measured at pre-defined timepoints from the screening visit until the end-of-study visit, an average of 10 days in Part I (SAD) and 20 days in Part II (MAD).
Single 12-lead ECG was recorded in supine position after 10 minutes of rest using an ECG machine. Heart rate and PQ/PR, QRS, QT and QTcF intervals were recorded. Ambulatory ECG telemetry was used for cardiac surveillance up to 24 h after IMP administration in the SAD part of the study.
Clinically Significant Changes in Vital Signs
Time frame: Vital signs was checked at pre-defined timepoints from the screening visit until the end-of-study visit, an average of 10 days in Part 1 (SAD) and 20 days in Part 2 (MAD).
Systolic and diastolic blood pressure and pulse were measured in supine position after 10 minutes of rest. Body temperature was measured orally using a digital thermometer.
Clinically Significant Changes in Safety Laboratory Parameters
Time frame: Blood samples were collected at pre-defined timepoints from the screening visit until the end-of-study visit, an average of 10 days in Part I (SAD) and 20 days in Part II (MAD).
Blood samples for analysis of clinical chemistry, haematology and coagulation parameters.
Clinically Significant Changes in Physical Examination
Time frame: Physical examination was performed at pre-defined timepoints from the screening visit until the end-of- study visit, an average of 10 days in Part I (SAD) and 20 days in Part II (MAD).
A complete physical examination included assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities.

9 secondary outcomes

Cmax:
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose; MAD Day 1-3 (first dose) and Day 10-12 (last dose): pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
Tmax:
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose; MAD: Day 1-3 (first dose) Day 10-12 (last dose): pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
T½:
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose); MAD: Day 1-3 and Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
AUC0-t:
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose); MAD: Day 1-3 and Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
AUC 0-inf
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose
AUCss
Time frame: MAD: Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
Clearance (CL)/F:
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose); MAD Day 1-3 and Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
Vz/F:
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose); MAD: Day 1-3 and Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.
Accumulation Ratio AUC 0-ss
Time frame: MAD: Day 1-3 and Day 10-12: pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose.

Results and safety

Results posted to the registry on 8 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part I (SAD): 1 mg	6	6
Part I (SAD): 5 mg	0	0
Part I (SAD): 8 mg	0	0
Part I (SAD): 40 mg	0	0
Part I (SAD): 100 mg	0	0
Part I (SAD): 300 mg	0	0
Part I (SAD): Placebo	0	0
Part II (MAD): 20 mg	0	0
Part II (MAD): 60 mg	0	0
Part II (MAD): 180 mg	0	0
Part II (MAD): Placebo	0	0

Primary outcome: Number of Treatment Related Adverse Events

Time frame: AEs were collected from the start of IMP administration until the end-of-study visit of each part, an average of 10 days in Part 1 (SAD) and 20 days in Part 2 (MAD).. Number. Unit: Number of events

Measure	GS-248 1 mg (SAD) n = 6	GS-248 5 mg (SAD) n = 6	GS-248 8 mg (SAD) n = 6	GS-248 40 mg (SAD) n = 6	GS-248 100 mg (SAD) n = 6	GS-248 300 mg (SAD) n = 6	Placebo (SAD) n = 12	GS-248 20 mg (MAD) n = 6	GS-248 60 mg (MAD) n = 6	GS-248 180 mg (MAD) n = 6	Placebo (MAD) n = 6
Value	3	4	0	3	2	1	4	1	12	9	0

Population analysed: All subjects who have been randomised and received at least one dose of IMP.

Primary outcome: Clinically Significant Changes in ECG

Time frame: 12-lead ECG was measured at pre-defined timepoints from the screening visit until the end-of-study visit, an average of 10 days in Part I (SAD) and 20 days in Part II (MAD).. Number. Unit: Number of abnormal CS events

Measure	GS-248 1 mg (SAD) n = 6	GS-248 5 mg (SAD) n = 6	GS-248 8 mg (SAD) n = 6	GS-248 40 mg (SAD) n = 6	GS-248 100 mg (SAD) n = 6	GS-248 300 mg (SAD) n = 6	Placebo (SAD) n = 12	GS-248 20 mg (MAD) n = 6	GS-248 60 mg (MAD) n = 6	GS-248 180 mg (MAD) n = 6	Placebo (MAD) n = 6
Value	0	0	0	0	0	0	0	1	0	0	0

Population analysed: All subjects who have been randomised and received at least one dose of IMP.

Primary outcome: Clinically Significant Changes in Vital Signs

Time frame: Vital signs was checked at pre-defined timepoints from the screening visit until the end-of-study visit, an average of 10 days in Part 1 (SAD) and 20 days in Part 2 (MAD).. Number. Unit: Number of abnormal CS events

Measure	GS-248 1 mg (SAD) n = 6	GS-248 5 mg (SAD) n = 6	GS-248 8 mg (SAD) n = 6	GS-248 40 mg (SAD) n = 6	GS-248 100 mg (SAD) n = 6	GS-248 300 mg (SAD) n = 6	Placebo (SAD) n = 12	Total (SAD) n = 48	GS-248 20 mg (MAD) n = 6	GS-248 60 mg (MAD) n = 6	GS-248 180 mg (MAD) n = 6	Placebo (MAD) n = 6	Total (MAD) n = 24
Value	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All subjects who have been randomised and received at least one dose of IMP.

Primary outcome: Clinically Significant Changes in Safety Laboratory Parameters

Time frame: Blood samples were collected at pre-defined timepoints from the screening visit until the end-of-study visit, an average of 10 days in Part I (SAD) and 20 days in Part II (MAD).. Count of participants. Unit: Participants

Measure	GS-248 1 mg (SAD) n = 6	GS-248 5 mg (SAD) n = 6	GS-248 8 mg (SAD) n = 6	GS-248 40 mg (SAD) n = 6	GS-248 100 mg (SAD) n = 6	GS-248 300 mg (SAD) n = 6	Placebo (SAD) n = 12	Total (SAD) n = 48	GS-248 20 mg (MAD) n = 6	GS-248 60 mg (MAD) n = 6	GS-248 180 mg (MAD) n = 6	Placebo (MAD) n = 6	Total (MAD) n = 24
Value	0	0	0	0	0	0	0	0	0	2	0	1	3

Population analysed: All subjects who have been randomised and received at least one dose of IMP.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs (including serious AEs [SAEs]) were collected from the start of IMP application until the end-of- study visit of each part, an average of 10 days in Part I (SAD) and 20 days in Part II (MAD).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part I (SAD): 1 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part I (SAD): 5 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part I (SAD): 8 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part I (SAD): 40 mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part I (SAD): 100 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part I (SAD): 300 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part I (SAD): Placebo	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Part II (MAD): 20 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part II (MAD): 60 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part II (MAD): 180 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part II (MAD): Placebo	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Limitations and caveats (from the sponsor): Part I=SAD was completed in full. Part II=MAD was completed after three of four cohorts. Reason: Systemic exposure of GS-248 was considered sufficiently high after 3 MAD cohorts. Part III= Systemic sclerosis patients was cancelled. Reason: Decision by Sponsor that performing this part would not add scientific value to the development programme for GS-248. Part IV=Celecoxib was completed in full. Only celecoxib given in this exploratory comparison and thus results excluded in result section.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Folke Sjöberg, MD principal investigator

CTC Clinical Trial Consultants AB

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 GS-248 in people with Healthy, run by Gesynta Pharma AB 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 25 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 11 Oct 2023. 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?

Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Treatment Related Adverse Events (time frame: AEs were collected from the start of IMP administration until the end-of-study visit of each part, an average of 10 days in Part 1 (SAD) and 20 days in Part 2 (MAD).). The study lists 5 primary outcomes in all. 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 NCT04036227.

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 11 Oct 2023.