Solid TumorPhase 1NCT04508179
A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects
A Phase 1 study testing 7HP349 Single Ascending Dose, 7HP349 Multiple Ascending Dose and 7HP349 Food Effect in people with Solid Tumor, run by 7 Hills Pharma, LLC at 1 site in United States.
Trial summary
This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor
- What is being tested?
- 7HP349 Single Ascending Dose, 7HP349 Multiple Ascending Dose and 7HP349 Food Effect
- 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 siteUnited States
- Study dates
- 28 Oct 2020to 25 Oct 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between the ages of 18 and 45 years, inclusive
- Normal clinical chemistry, hepatic function, hematology, thyroid function
- Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 60 kg
- Agree to refrain from consuming products containing grapefruit, pomelo, star fruit or Seville oranges for at least 7 days before the first dose of study drug until the final discharge evaluation
- Positive immune status as defined in serum as measles, mumps, varicella-zoster viruses (VZR); Antibody Index (AI) ≥ 1.1, and positive Rubella: AI ≥ 1.0
Who cannot join
- Clinically significant history of disorders, infections or drug hypersensitivity as determined by the Investigator
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
- Current treatment or treatment within 30 days with another investigational medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services Inc.
Secaucus, New Jersey, 07094
About this study
Official title: A Phase 1, Placebo-controlled, Within-Cohort Randomized, Double-blind, Single and Multiple Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of 7HP349 in Normal Healthy Male Subjects
This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects
Read the detailed description
This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following single and multiple oral dose administration to healthy male subjects, with a separate, open-label food effect cohort at the optimal pharmacokinetic dose (OPD). The study will be carried out in 3 parts.
Part A: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, single ascending dose (SAD) escalation study to determine the safety, tolerability and PK of 7HP349 following administration of single oral doses in healthy male subjects, and to define the OPD of 7HP349.
Part B: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, multiple ascending dose (MAD) escalation study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects.
Part C: This is a randomized, open label, two-treatment, three-period, crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
- Conditions
- Solid Tumor
- Being tested
- 7HP349 Single Ascending Dose, 7HP349 Multiple Ascending Dose, Placebo Single Ascending Dose, Placebo Multiple Ascending Dose, 7HP349 Food Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7HP349 Single Ascending DoseDrug
Also called 7HP349 SAD
Part A: 7HP349 Capsules, Single Ascending Dose (SAD)
7HP349 Multiple Ascending DoseDrug
Also called 7HP349 MAD
Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD)
Placebo Single Ascending DoseDrug
Also called Placebo SAD
Part A: Placebo Capsules, Single Ascending Dose (SAD)
Placebo Multiple Ascending DoseDrug
Also called Placebo MAD
Part B: Placebo Capsules, Multiple Ascending Dose (MAD)
7HP349 Food EffectDrug
Also called 7HP349 FE
Part C: 7HP349 Capsules, Food Effect
| Study group | Role | What they receive |
|---|---|---|
| 7HP349 Capsules | Experimental | Part A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (3-period cross-over) Receives: Drug: 7HP349 Single Ascending Dose; Drug: 7HP349 Multiple Ascending Dose; Drug: 7HP349 Food Effect |
| Placebo Capsules | Placebo comparator | Part A: Placebo Capsules (5 cohorts); Part B: Placebo Capsules (2 cohorts) Receives: Drug: Placebo Single Ascending Dose; Drug: Placebo Multiple Ascending Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of 7HP349 in healthy male subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria
Safety assessments will include evaluation of incidence of treatment-emergent adverse events (AEs) according to CTCAE v5.0 criteria, including vital signs, resting electrocardiogram (ECG) parameters, standard hematology, chemistry, urinalysis and other tests
Measured: 17 days
Secondary outcomes (10)
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose (OPD)
Determination of maximum plasma concentration (Cmax)
Measured: 17 days
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by plasma exposure (AUClast and/or AUCinf) towards determination of the optimal pharmacokinetic dose (OPD)
Determination of plasma exposure (AUClast and/or AUCinf)
Measured: 17 days
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by exposure in urine towards determination of the optimal pharmacokinetic dose (OPD)
Determination of exposure in urine
Measured: 17 days
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by renal clearance (CLr) towards determination of the optimal pharmacokinetic dose (OPD)
Determination of renal clearance (CLr)
Measured: 17 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fed individuals
Fed prandial state, determination of maximum plasma concentration (Cmax)
Measured: 28 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fed individuals
Fed prandial state, determination of plasma exposure (AUClast and/or AUCinf)
Measured: 28 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fasted individuals
Fasted prandial state, determination of maximum plasma concentration (Cmax)
Measured: 28 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fasted individuals
Fasted prandial state, determination of plasma exposure (AUClast and/or AUCinf)
Measured: 28 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the maximum plasma concentration (Cmax) in fed vs. fasted individuals
Determination of Geometric Mean Ratio (GMR) of fed:fasted Cmax
Measured: 28 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the plasma exposure (AUClast and/or AUCinf) in fed vs. fasted individuals
Determination of Geometric Mean Ratio (GMR) of fed:fasted AUClast and/or AUCinf
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start28 Oct 2020
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Model description
- This study consists of three parts, Part A, Part B and Part C, which will be undertaken sequentially. Part A is a SAD study to determine the safety, tolerability and PK of 7HP349 in healthy male subjects, and to define the OPD. Part B is a MAD study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects. Part C is a crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- 7 Hills Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Frontage Clinical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508179
- Sponsor's protocol ID
- 7HP-101a
- Status last verified
- Oct 2021
- First submitted
- 5 Aug 2020
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-controlled, Within-Cohort Randomized, Double-blind, Single and Multiple Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of 7HP349 in Normal Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04508179
- Acronym / sponsor ID
- 7HP-101a
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- 7 Hills Pharma, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Frontage Clinical Services, Inc.
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 11 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.
This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects
Detailed description
This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following single and multiple oral dose administration to healthy male subjects, with a separate, open-label food effect cohort at the optimal pharmacokinetic dose (OPD). The study will be carried out in 3 parts.
Part A: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, single ascending dose (SAD) escalation study to determine the safety, tolerability and PK of 7HP349 following administration of single oral doses in healthy male subjects, and to define the OPD of 7HP349.
Part B: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, multiple ascending dose (MAD) escalation study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects.
Part C: This is a randomized, open label, two-treatment, three-period, crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study consists of three parts, Part A, Part B and Part C, which will be undertaken sequentially. Part A is a SAD study to determine the safety, tolerability and PK of 7HP349 in healthy male subjects, and to define the OPD. Part B is a MAD study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects. Part C is a crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
| Arm | Type | Receives |
|---|---|---|
| 7HP349 Capsules | Experimental | Drug: 7HP349 Single Ascending Dose, Drug: 7HP349 Multiple Ascending Dose, Drug: 7HP349 Food EffectPart A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (3-period cross-over) |
| Placebo Capsules | Placebo comparator | Drug: Placebo Single Ascending Dose, Drug: Placebo Multiple Ascending DosePart A: Placebo Capsules (5 cohorts); Part B: Placebo Capsules (2 cohorts) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males between the ages of 18 and 45 years, inclusive
- Normal clinical chemistry, hepatic function, hematology, thyroid function
- Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 60 kg
- Agree to refrain from consuming products containing grapefruit, pomelo, star fruit or Seville oranges for at least 7 days before the first dose of study drug until the final discharge evaluation
- Positive immune status as defined in serum as measles, mumps, varicella-zoster viruses (VZR); Antibody Index (AI) ≥ 1.1, and positive Rubella: AI ≥ 1.0
Key exclusion criteria (4 listed)
- Clinically significant history of disorders, infections or drug hypersensitivity as determined by the Investigator
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
- Current treatment or treatment within 30 days with another investigational medication
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 |
|---|---|---|
| 7HP349 Single Ascending DoseAlso: 7HP349 SADPart A: 7HP349 Capsules, Single Ascending Dose (SAD) | Drug | 7HP349 Capsules |
| 7HP349 Multiple Ascending DoseAlso: 7HP349 MADPart B: 7HP349 Capsules, Multiple Ascending Dose (MAD) | Drug | 7HP349 Capsules |
| Placebo Single Ascending DoseAlso: Placebo SADPart A: Placebo Capsules, Single Ascending Dose (SAD) | Drug | Placebo Capsules |
| Placebo Multiple Ascending DoseAlso: Placebo MADPart B: Placebo Capsules, Multiple Ascending Dose (MAD) | Drug | Placebo Capsules |
| 7HP349 Food EffectAlso: 7HP349 FEPart C: 7HP349 Capsules, Food Effect | Drug | 7HP349 Capsules |
Primary outcome
Safety and tolerability of 7HP349 in healthy male subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria
Time frame: 17 days
Safety assessments will include evaluation of incidence of treatment-emergent adverse events (AEs) according to CTCAE v5.0 criteria, including vital signs, resting electrocardiogram (ECG) parameters, standard hematology, chemistry, urinalysis and other tests
10 secondary outcomes
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose (OPD)
Time frame: 17 days
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by plasma exposure (AUClast and/or AUCinf) towards determination of the optimal pharmacokinetic dose (OPD)
Time frame: 17 days
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by exposure in urine towards determination of the optimal pharmacokinetic dose (OPD)
Time frame: 17 days
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by renal clearance (CLr) towards determination of the optimal pharmacokinetic dose (OPD)
Time frame: 17 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fed individuals
Time frame: 28 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fed individuals
Time frame: 28 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fasted individuals
Time frame: 28 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fasted individuals
Time frame: 28 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the maximum plasma concentration (Cmax) in fed vs. fasted individuals
Time frame: 28 days
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the plasma exposure (AUClast and/or AUCinf) in fed vs. fasted individuals
Time frame: 28 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 2 Nov 2021.
- 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.
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 7HP349 Single Ascending Dose, 7HP349 Multiple Ascending Dose and 7HP349 Food Effect in people with Solid Tumor, run by 7 Hills Pharma, LLC at 1 site in United States.
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 4 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 2 Nov 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 United States. 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?
Safety and tolerability of 7HP349 in healthy male subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria (time frame: 17 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 2 Nov 2021.