OsteoporosisPhase 1NCT04036617
Study of NaQuinate in Healthy Volunteers
A Phase 1 study testing NaQuinate in people with Osteoporosis, run by Haoma Medica Limited at 1 site in United Kingdom.
Trial summary
Phase 1, randomised, double-blind, placebo-controlled study of NaQuinate in healthy subjects after single ascending oral (PO) doses and multiple ascending PO doses. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- NaQuinate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2019to 30 May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who meet the following criteria will be considered eligible to participate in the clinical study:
- Healthy male and female subjects (women of non-childbearing potential) between 18 and 55 years of age. Note: Women of non-childbearing potential is defined as being amenorrhoeic for >12 months with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). However, if indicated, this should be confirmed by follicle-stimulation hormone (FSH) levels consistent with menopause (according to local laboratory ranges). Or, have been permanently sterilised (e.g. hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
- The subject is healthy as determined by past medical history and as judged by the PI or designee.
- The subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening procedures.
- The subject has a BMI of 18-32 kg/m2, inclusive, at Screening.
- The subject has no clinically significant history of previous allergy or sensitivity to NaQuinate or any of the excipients contained within the IMP.
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- The subject has no clinically significant abnormal serum biochemistry, haematology, coagulation and urine examination values within 28 days before the first dose of IMP.
- The subject has no clinically significant abnormalities in 12-lead electrocardiogram (QTcF ≤ 450 mSec and PR 120-220 mSec).
- Male subjects and their female spouse/partner of childbearing potential must use appropriate effective methods of contraception from the time of dosing until after the end-of-study (EOS) visit. See Section 7.5.2 for protocol-specified contraception guidance.
- Male subjects must not donate sperm from first dose until at least 3 months after last dose of IMP.
- The subject is a non-smoker, defined as a subject who has not smoked previously and/or who has discontinued smoking or the use of nicotine/nicotine-containing products (including snuff and similar products) at least 3 months before the Screening visit.
- The subject must be available to complete the study (including all Follow-up visits).
- The subject must satisfy the PI / designee about their fitness to participate in the study and agree to comply with the protocol requirements, instructions, and study related restrictions
Who cannot join
- Subjects who meet one or more of the following criteria will not be considered eligible to participate in the clinical study:
- Female subjects who are breastfeeding or female subjects with a positive serum pregnancy test at Screening or a positive urine pregnancy test on Day -1.
- Subjects who have donated blood in the 3 months prior to Screening, plasma in the 7 days prior to Screening or platelets in the 6 weeks prior to Screening.
- A positive urine cotinine result at Screening or on Day -1.
- Subjects who have used the following within 7 days of first dosing: any non-prescribed systemic or topical medication (with the exception of paracetamol to a maximum of 2 g per day), remedy or supplement, any prescribed systemic or topical medication within 14 days of first dosing.
- Subjects who have clinically significant abnormalities in vital signs including: Systolic BP < 90 mmHG or > 140 mmHg; Diastolic BP < 50 mmHG or > 90 mmHG; Pulse rate < 45 or > 90 beats per minute.
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- Subjects who have a history of significant drug allergy (e.g., anaphylaxis) or any clinically significant allergic condition (excluding hay fever), as determined by the PI.
- Any clinically significant abnormal haematology results, as determined by the PI.
- Subjects who have a confirmed positive urine drugs of abuse screen at Screening or Day -1, or a confirmed positive urine alcohol test at Screening or Day -1 (N.B. a positive alcohol result may be repeated at the Investigator's discretion) or subjects who are unwilling to avoid the use of alcohol within 48 hours before any study visit and while confined to the clinical unit.
- Subjects who received last IMP dose in a clinical study within the following time period prior to dosing: 3 months or 5 half-lives, whichever is longer.
- Subjects who have had a clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of dosing, as determined by the PI.
- A positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV 2) at Screening.
- Vulnerable subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons in detention, minors and those incapable of giving consent).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Parexel Early Phase Clinical Unit - London
London, HA1 3UJ
Muna Albayaty, MBChB, +44 189 561 4592, muna.albayaty@PAREXEL.com
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of NaQuinate in Healthy Volunteers
Phase 1, randomised, double-blind, placebo-controlled study of NaQuinate in healthy subjects after single ascending oral (PO) doses and multiple ascending PO doses.
Read the detailed description
This first-in-human (FIH) clinical study is a Phase 1, randomised, double-blind, placebo-controlled study to assess the safety, tolerability, and PK of NaQuinate in healthy subjects after single ascending oral (PO) doses and multiple ascending PO doses.
- Conditions
- Osteoporosis
- Being tested
- NaQuinate, Placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaQuinateDrug
SAD cohorts will receive 1 dose between 10-150 mg. MAD cohorts will receive 7 days dosing between 70-150mg
PlaceboDrug
SAD cohorts will receive 1 dose of placebo between 10-150 mg. MAD cohorts will receive 7 days dosing of placebo between 70-150mg
| Study group | Role | What they receive |
|---|---|---|
| NaQuinate | Experimental | Initial SAD cohorts will receive 1 dose between 10-150 mg. MAD cohorts will receive 7 days dosing between 70-150 mg Receives: Drug: NaQuinate |
| Placebo | Experimental | Initial SAD cohorts will receive 1 placebo dose between 10-150 mg . MAD cohorts will receive 7 days placebo dosing between 70-150 mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety by assessment of AEs, of NaQuinate in healthy volunteers
safety of single and multiple doses of NaQuinate as assess by the number of participants with treatment-related adverse events evaluated by the PI for their intensity, causality and severity, including Adverse events of Special interest.
Measured: approximately 8 weeks
To investigate the tolerability by assessment of AEs, of NaQuinate in healthy volunteers
tolerability of single and multiple doses of NaQuinate as assess by the number of participants with treatment-related adverse events evaluated by the PI for their intensity, causality and severity, including Adverse events of Special interest.
Measured: approximately 8 weeks
Secondary outcomes (1)
to Investigate the pharmacokinetics by measurment of Cmax of exposure to NaQuinate in healthy volunteers
PK parameters after single or multiple dose administration measured by Cmax of exposure to NaQuninate in healthy volunteers
Measured: approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start18 Jun 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haoma Medica Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Muna Albayaty, MBChB, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036617
- Sponsor's protocol ID
- HML-1/01/001
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of NaQuinate in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04036617
- Acronym / sponsor ID
- HML-1/01/001
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Haoma Medica LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 30 Jul 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.
Phase 1, randomised, double-blind, placebo-controlled study of NaQuinate in healthy subjects after single ascending oral (PO) doses and multiple ascending PO doses.
Detailed description
This first-in-human (FIH) clinical study is a Phase 1, randomised, double-blind, placebo-controlled study to assess the safety, tolerability, and PK of NaQuinate in healthy subjects after single ascending oral (PO) doses and multiple ascending PO doses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NaQuinate | Experimental | Drug: NaQuinateInitial SAD cohorts will receive 1 dose between 10-150 mg. MAD cohorts will receive 7 days dosing between 70-150 mg |
| Placebo | Experimental | Drug: PlaceboInitial SAD cohorts will receive 1 placebo dose between 10-150 mg . MAD cohorts will receive 7 days placebo dosing between 70-150 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects who meet the following criteria will be considered eligible to participate in the clinical study:
Key exclusion criteria (13 listed)
- Subjects who meet one or more of the following criteria will not be considered eligible to participate in the clinical study:
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 |
|---|---|---|
| NaQuinateSAD cohorts will receive 1 dose between 10-150 mg. MAD cohorts will receive 7 days dosing between 70-150mg | Drug | NaQuinate |
| PlaceboSAD cohorts will receive 1 dose of placebo between 10-150 mg. MAD cohorts will receive 7 days dosing of placebo between 70-150mg | Drug | Placebo |
Primary outcome
To investigate the safety by assessment of AEs, of NaQuinate in healthy volunteers
Time frame: approximately 8 weeks
safety of single and multiple doses of NaQuinate as assess by the number of participants with treatment-related adverse events evaluated by the PI for their intensity, causality and severity, including Adverse events of Special interest.
To investigate the tolerability by assessment of AEs, of NaQuinate in healthy volunteers
Time frame: approximately 8 weeks
tolerability of single and multiple doses of NaQuinate as assess by the number of participants with treatment-related adverse events evaluated by the PI for their intensity, causality and severity, including Adverse events of Special interest.
1 secondary outcome
to Investigate the pharmacokinetics by measurment of Cmax of exposure to NaQuinate in healthy volunteers
Time frame: approximately 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- 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.
Muna Albayaty, MBChB principal investigator
Parexel
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 NaQuinate in people with Osteoporosis, run by Haoma Medica Limited at 1 site in United Kingdom.
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 13 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: status not confirmed, as of the sponsor's last update on 30 Jul 2019. 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 Kingdom. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact julia m tilson (+44 (0)7725 844778, julia.tilson@haomamedica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the safety by assessment of AEs, of NaQuinate in healthy volunteers (time frame: approximately 8 weeks). 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 30 Jul 2019.