HIV PreventionEarly Phase 1NCT04791007
OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults
A Early Phase 1 study testing OB-002 in people with HIV Prevention, run by Orion Biotechnology Polska Sp. z o.o. at 1 site in Poland.
Trial summary
This is a monocentric phase I study in open-label and randomized, double-blind, placebo-controlled cohorts of HIV-1 seronegative adults to evaluate the safety, acceptability, and pharmacokinetic of OB-002H Gel administrated vaginally and rectally. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- OB-002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 5 Oct 2019to 31 Aug 2020
- Phase
- Early 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
- Age between 18 and 45 years (inclusive).
- HIV-1 antibody negative as documented at screening.
- Understands and agrees to local sexually transmitted infection (STI) reporting requirements.
- Able and willing to provide written informed consent to take part in the trial.
- Willing and able to return for a follow-up visit one week after last IMP administration, barring unforeseen circumstances.
- Of good general health in the opinion of the investigator.
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- Willing to be sexually abstinent (anal and vaginal sex) for 72 hours before and after each visit except Visit 1.
- No participation in other clinical trials within the last three months prior Visit 1 and throughout the trial.
- Willing to abstain from inserting any non-trial products for rectal or vaginal application for 72 hours prior to each trial visit.
- For female participants only:
- Using (or willing to use) highly effective (i.e. failure rate <1% per year) methods of contraception for the duration of trial participation. Such methods include combined oral or transdermal hormonal contraception associated with inhibition of ovulation, oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device [IUD] or intrauterine hormone-releasing system [IUS] inserted at least 28 days prior to the Screening Visit, bilateral tubal occlusion, surgical sterilization, successful vasectomisation of male partner or sexually abstinent for the past 90 days and during the trial. If the female participant has female partners only, the method of contraception will be noted as abstinence to heterosexual activities in the trial documentation.
- Not pregnant at the screening.
- Not breastfeeding at screening nor intending to breastfeed during trial participation per participant report.
- In addition, participants enrolled in the corresponding cohorts must meet the following criteria:
- Cohorts A1 and B1 only: Willing to stay at the site overnight for two nights.
- Cohort A2 only: Willing to stay at the site overnight for six nights.
- Cohort A3 only: Willing to stay at the site overnight from Day 1 to Day 2 and from Day 5 to Day 6 for PK blood sampling.
Who cannot join
- Following laboratory findings at screening:
- Haemoglobin < 10.0 g/dL
- Platelet count < 100 000/mm3
- White blood cell count < 2 000 cells/mm3 or > 15 000 cells/mm3
- Glomerular filtration rate (GFR) < 60 mL/min/1.73 m2
- Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5× laboratory upper limit of normal (ULN)
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- Abnormal glucose or protein on urinalysis (UA)
- Known allergy or intolerance to any of the IMP excipients (sodium sorbate, sodium chloride, acetic acid, natrasol).
- By participant report at screening: Use of post-exposure prophylaxis (PEP) for HIV exposure, systemic immunomodulatory medications vaginally or rectally administered medications, and vaginally or rectally administered products (including condoms) containing nonoxynol-9 (N-9) within the last four weeks prior to Visit 1.
- Any significant underlying medical condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make trial participation unsafe, make the individual unsuitable for the trial or unable to comply with the trial requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cardiovascular, immunological or cerebral disease.
- Abnormalities of the cervical (females only), vaginal (females only), or colorectal mucosa, or significant symptom(s), which in the opinion of the clinician represents a contraindication to protocol-required biopsies (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external haemorrhoids).
- Suspected or confirmed drug or alcohol abuse.
- Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) test results. HSV-1 or HSV-2 seropositive diagnosis will only be allowed if no active lesions are present and since treatment is not required.
- Body mass index (BMI) < 18 or > 30 kg/m2.
- Previous enrolment to any preceding cohort of this trial.
- Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
- In addition to the criteria listed above, female participants will be excluded if they meet any of the following criteria:
- Last pregnancy outcome or gynaecological surgery within 90 days prior to screening
- Chronic and/or recurrent symptomatic vaginal candidiasis at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Monocentric Phase I Safety, Acceptability, and Pharmacokinetic Trial of OB-002H Gel Administered Vaginally and Rectally in Open-Label and Randomised, Double- Blind, Placebo-Controlled Cohorts of HIV-1 Seronegative Adults
This is a monocentric phase I study in open-label and randomized, double-blind, placebo-controlled cohorts of HIV-1 seronegative adults to evaluate the safety, acceptability, and pharmacokinetic of OB-002H Gel administrated vaginally and rectally.
- Conditions
- HIV Prevention
- Being tested
- OB-002, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OB-002Drug
vaginal or rectal administration
PlaceboDrug
vaginal or rectal administration
| Study group | Role | What they receive |
|---|---|---|
| Single dose administration (Part 1) | Experimental | the dose of the drug (4g OB-002H (8.0 mg/g)) administrated once vaginally or rectally Receives: Drug: OB-002 |
| Multidose administration (Part 2) | Experimental | the dose of the drug (4g OB-002H (8.0 mg/g)) or placebo administered vaginally through five consecutive days Receives: Drug: OB-002; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of OB-002H gel after single- and multiple-dose application based on the number of observed AEs
For the primary safety analysis, the number of ≥ Grade 2 AEs, as well as the number and the percentage of participants with corresponding AEs, will be tabulated overall and per cohort, by system organ class (SOC) and by preferred term (PT).
Additional AE analyses will also tabulate the number of AEs ≥ Grade 2 observed overall, by relationship and by severity. AEs ≥ Grade 2 that lead to discontinuation of trial participation will be tabulated separately. The safety set will be used for the primary safety analysis.
Measured: approximately 5 weeks for single dose and approximately five to seven weeks for multi-dose
Secondary outcomes (6)
Acceptability
Participants will receive a placebo sample to check and evaluate the OB-002H gel and will be asked to answer the questions in the questionnaire with Likert scale
Measured: assessment done on the visit conducted 24 hours after IMP administration
OB-002 serum concentration at different time points for the calculation of PK parameters (area under the concentration-time curve (AUC).
In each Part of the trial, the parameters will be summarised descriptively by cohort and treatment arm (Part 2 only: OB-002H and placebo).
Measured: Serum samples collected within 24 hours after dosing
OB-002 serum concentration at different time points for the calculation of PK parameters (maximum concentration (Cmax).
In each Part of the trial, the parameters will be summarised descriptively by cohort and treatment arm (Part 2 only: OB-002H and placebo).
Measured: Serum samples collected within 24 hours after dosing
OB-002 serum concentration at different time points for the calculation of PK parameters (time to maximum concentration (tmax).
In each Part of the trial, the parameters will be summarised descriptively by cohort and treatment arm (Part 2 only: OB-002H and placebo).
Measured: Serum samples collected within 24 hours after dosing
OB-002 serum concentration at different time points for the calculation of PK parameters (minimum concentration (Cmin).
In each Part of the trial, the parameters will be summarised descriptively by cohort and treatment arm (Part 2 only: OB-002H and placebo).
Measured: Serum samples collected within 24 hours after dosing
OB-002 serum concentration at different time points for the calculation of PK parameters (concentration half-life (t½).
In each Part of the trial, the parameters will be summarised descriptively by cohort and treatment arm (Part 2 only: OB-002H and placebo).
Measured: Serum samples collected within 24 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start5 Oct 2019
- Primary completion6 Apr 2020
- Study completion31 Aug 2020
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 HIV PreventionStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Biotechnology Polska Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scope International AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791007
- Sponsor's protocol ID
- OB-002H-101
- Status last verified
- Mar 2021
- First submitted
- 2 Feb 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGowan IM, Tzakis N, Kosak B, Korczak B, Engstrom J, Tomaszewska-Kiecana M, Hartley O. Evaluation of the Safety, Acceptability, and Pharmacokinetic Profile of a Gel Formulation of OB-002 in Healthy Volunteers. AIDS Res Hum Retroviruses. 2021 Jun;37(6):453-460. doi: 10.1089/AID.2021.0010. Epub 2021 Apr 30.
PubMed 33749321
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric Phase I Safety, Acceptability, and Pharmacokinetic Trial of OB-002H Gel Administered Vaginally and Rectally in Open-Label and Randomised, Double- Blind, Placebo-Controlled Cohorts of HIV-1 Seronegative Adults
- ClinicalTrials.gov ID
- NCT04791007
- Acronym / sponsor ID
- OB-002H-101
- Conditions
- HIV Prevention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Orion Biotechnology Polska Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- Scope International AG
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 10 Mar 2021 (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 is a monocentric phase I study in open-label and randomized, double-blind, placebo-controlled cohorts of HIV-1 seronegative adults to evaluate the safety, acceptability, and pharmacokinetic of OB-002H Gel administrated vaginally and rectally.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose administration (Part 1) | Experimental | Drug: OB-002the dose of the drug (4g OB-002H (8.0 mg/g)) administrated once vaginally or rectally |
| Multidose administration (Part 2) | Experimental | Drug: OB-002, Drug: Placebothe dose of the drug (4g OB-002H (8.0 mg/g)) or placebo administered vaginally through five consecutive days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age between 18 and 45 years (inclusive).
- HIV-1 antibody negative as documented at screening.
- Understands and agrees to local sexually transmitted infection (STI) reporting requirements.
- Able and willing to provide written informed consent to take part in the trial.
- Willing and able to return for a follow-up visit one week after last IMP administration, barring unforeseen circumstances.
Key exclusion criteria (19 listed)
- Following laboratory findings at screening:
- Known allergy or intolerance to any of the IMP excipients (sodium sorbate, sodium chloride, acetic acid, natrasol).
- By participant report at screening: Use of post-exposure prophylaxis (PEP) for HIV exposure, systemic immunomodulatory medications vaginally or rectally administered medications, and vaginally or rectally administered products (including condoms) containing nonoxynol-9 (N-9) within the last four weeks prior to Visit 1.
- Any significant underlying medical condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make trial participation unsafe, make the individual unsuitable for the trial or unable to comply with the trial requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cardiovascular, immunological or cerebral disease.
- Abnormalities of the cervical (females only), vaginal (females only), or colorectal mucosa, or significant symptom(s), which in the opinion of the clinician represents a contraindication to protocol-required biopsies (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external haemorrhoids).
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 |
|---|---|---|
| OB-002vaginal or rectal administration | Drug | Multidose administration (Part 2), Single dose administration (Part 1) |
| Placebovaginal or rectal administration | Drug | Multidose administration (Part 2) |
Primary outcome
To evaluate the safety of OB-002H gel after single- and multiple-dose application based on the number of observed AEs
Time frame: approximately 5 weeks for single dose and approximately five to seven weeks for multi-dose
For the primary safety analysis, the number of ≥ Grade 2 AEs, as well as the number and the percentage of participants with corresponding AEs, will be tabulated overall and per cohort, by system organ class (SOC) and by preferred term (PT). Additional AE analyses will also tabulate the number of AEs ≥ Grade 2 observed overall, by relationship and by severity. AEs ≥ Grade 2 that lead to discontinuation of trial participation will be tabulated separately. The safety set will be used for the primary safety analysis.
6 secondary outcomes
Acceptability
Time frame: assessment done on the visit conducted 24 hours after IMP administration
OB-002 serum concentration at different time points for the calculation of PK parameters (area under the concentration-time curve (AUC).
Time frame: Serum samples collected within 24 hours after dosing
OB-002 serum concentration at different time points for the calculation of PK parameters (maximum concentration (Cmax).
Time frame: Serum samples collected within 24 hours after dosing
OB-002 serum concentration at different time points for the calculation of PK parameters (time to maximum concentration (tmax).
Time frame: Serum samples collected within 24 hours after dosing
OB-002 serum concentration at different time points for the calculation of PK parameters (minimum concentration (Cmin).
Time frame: Serum samples collected within 24 hours after dosing
OB-002 serum concentration at different time points for the calculation of PK parameters (concentration half-life (t½).
Time frame: Serum samples collected within 24 hours after dosing
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 18 Mar 2021.
- Derived from this study: PubMed 33749321McGowan IM, Tzakis N, Kosak B, Korczak B, Engstrom J, Tomaszewska-Kiecana M, Hartley O. Evaluation of the Safety, Acceptability, and Pharmacokinetic Profile of a Gel Formulation of OB-002 in Healthy Volunteers. AIDS Res Hum Retroviruses. 2021 Jun;37(6):453-460. doi: 10.1089/AID.2021.0010. Epub 2021 Apr 30.
- 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.
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 Early Phase 1 study testing OB-002 in people with HIV Prevention, run by Orion Biotechnology Polska Sp. z o.o. at 1 site in Poland.
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 17 inclusion and 19 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 18 Mar 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 Poland. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
To evaluate the safety of OB-002H gel after single- and multiple-dose application based on the number of observed AEs (time frame: approximately 5 weeks for single dose and approximately five to seven weeks for multi-dose). 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 NCT04791007, 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 18 Mar 2021.