Spinal Cord InjuryPhase 1NCT05308953
A Phase I Safety Study of NVG-291 in Healthy Adults
A Phase 1 study testing NVG-291 in people with Spinal Cord Injury, run by NervGen Pharma at 1 site in Australia.
Trial summary
This is a randomized, triple-blind (subjects, Investigators, and Sponsor blinded), placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study to evaluate the safety and tolerability of NVG-291 administered by subcutaneous injection daily in healthy female participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- NVG-291
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteAustralia
- Study dates
- 6 May 2021to 3 Jul 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects between 18 and 65 years old.
- BMI between 18 and 33 kg/m2, inclusive, and a total body weight > 50 kg.
- All laboratory values must be within normal limits or any abnormalities deemed not clinically significant.
- All subjects must be willing to abstain from sexual intercourse or to use adequate contraception during the study and for an additional 120 days after the follow-up visit.
- Subjects must not donate ova or sperm during the study and for an additional 120 days after the follow-up visit
- Subjects must be willing and able to comply with scheduled visits, all sample collections, and other trial procedures.
- Subjects must provide written informed consent.
Who cannot join
- For premenopausal female subjects: Irregular menstrual cycles; Amenorrhea; or Abnormal vaginal bleeding
- A history (within the past year) or presence of a clinically significant infectious disease or hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, neurologic, or psychiatric abnormality.
- Blood pressure > 160/95 at screening or on Day -1.
- Any active or uncontrolled infections or other medical condition or circumstance that could interfere with the subject's participation in the study.
- History of allergic reaction to mannitol.
- Presence of a tattoo, piercing, scar, or other dermatologic abnormality at the injection site (abdomen), that might interfere with the ability to assess injection site reactions
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- a significant history of atopic dermatitis as an adult, or history of severe allergic reaction to injections.
- INR > 1.4 or PTT > 50 or platelets <50x10^3/µL at screening or on Day -1.
- History of regular alcohol consumption exceeding 10 units/week (1 unit = 83 mL of 12% wine) within 6 months of screening.
- Test positive for use of drugs or alcohol at screening.
- Positive hepatitis B, hepatitis C, or HIV test at screening.
- Blood or plasma donation within 1 week prior to Day -1.
- Receipt of an investigational drug within 30 days or five half-lives of the drug (whichever is longer) prior to Day -1.
- Prior participation in this trial.
- Female subjects who are breastfeeding or who have a positive pregnancy test at screening or Day -1.
- History of any condition that might impair the subject's ability to understand or to comply with the requirements of the study or to provide informed consent.
- Receipt of a COVID-19 vaccination within 3 weeks prior to Day -1
- Subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Triple-Blind, Placebo-Controlled Phase I Study of Single and Multiple Ascending Doses of NVG-291 in Healthy Subjects
This is a randomized, triple-blind (subjects, Investigators, and Sponsor blinded), placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study to evaluate the safety and tolerability of NVG-291 administered by subcutaneous injection daily in healthy female participants. The trial is split into three parts, starting with Part 1 (SAD), then Part 2 (MAD - post-menopausal Females), and finally Part 3 (MAD - males and premenopausal females). In Part 1 (SAD), participants receive 1 dose on 1 day only and in Parts 2 and 3, participants receive 1 dose every day for 14 days.
- Conditions
- Spinal Cord Injury
- Being tested
- NVG-291, Placebo
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVG-291Drug
NVG-291 is a drug injected under the skin (subcutaneous).
PlaceboOther
Salt water is being used as a placebo and will be injected under the skin (subcutaneous).
| Study group | Role | What they receive |
|---|---|---|
| NVG-291 SAD | Experimental | Doses will begin at the lowest dose level in Cohort 1, increasing in dose with each subsequent cohort to the highest dose level in Cohort 6 or until a maximum tolerated dose (MTD) is reached. Receives: Drug: NVG-291; Other: Placebo |
| NVG-291 MAD | Experimental | Participants will receive 1 dose daily for for 14 consecutive days. The maximum starting dose for MAD will be 2 dose levels lower than the maximum dose achieved during SAD. There will be a maximum of 3 dosing cohorts in Part 2. The maximum daily dose in Part 2 will not exceed the maximum daily dose tolerated in Part 1. Receives: Drug: NVG-291; Other: Placebo |
| NVG-291 MAD - Males and Premenopausal Females | Experimental | Participants will receive 1 dose daily for for 14 consecutive days. The dose maximum daily dose in Part 3 will not exceed the maximum daily dose tolerated in either Part 1 or 2. Receives: Drug: NVG-291; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
number and frequency of adverse events
Measured: Assessed through 7 days following the last dose of study drug
Secondary outcomes (2)
Pharmacokinetic analysis (plasma)
measure of concentration of drug in blood plasma
Measured: Assessed on Day 1 (SAD and MAD) and Day 14 (MAD only)
Immunogenicity analysis
number of participants with confirmed and titer results for the presence of anti-drug antibodies
Measured: Assessed on Day 1 (SAD and MAD), Day 8 (SAD and MAD) and Day 21 (MAD only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start6 May 2021
- Primary completion4 Jun 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- NervGen Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Miko, MD, Study director, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308953
- Sponsor's protocol ID
- NVG-291-101
- Status last verified
- Jan 2024
- First submitted
- 15 Mar 2022
- Last updated
- 10 Jan 2024
- 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-Blind, Placebo-Controlled Phase I Study of Single and Multiple Ascending Doses of NVG-291 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05308953
- Acronym / sponsor ID
- NVG-291-101
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- NervGen PharmaIndustry (pharma, biotech, devices)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 4 Apr 2022 (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 randomized, triple-blind (subjects, Investigators, and Sponsor blinded), placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study to evaluate the safety and tolerability of NVG-291 administered by subcutaneous injection daily in healthy female participants. The trial is split into three parts, starting with Part 1 (SAD), then Part 2 (MAD - post-menopausal Females), and finally Part 3 (MAD - males and premenopausal females). In Part 1 (SAD), participants receive 1 dose on 1 day only and in Parts 2 and 3, participants receive 1 dose every day for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NVG-291 SAD | Experimental | Drug: NVG-291, Other: PlaceboDoses will begin at the lowest dose level in Cohort 1, increasing in dose with each subsequent cohort to the highest dose level in Cohort 6 or until a maximum tolerated dose (MTD) is reached. |
| NVG-291 MAD | Experimental | Drug: NVG-291, Other: PlaceboParticipants will receive 1 dose daily for for 14 consecutive days. The maximum starting dose for MAD will be 2 dose levels lower than the maximum dose achieved during SAD. There will be a maximum of 3 dosing cohorts in Part 2. The maximum daily dose in Part 2 will not exceed the maximum daily dose tolerated in Part 1. |
| NVG-291 MAD - Males and Premenopausal Females | Experimental | Drug: NVG-291, Other: PlaceboParticipants will receive 1 dose daily for for 14 consecutive days. The dose maximum daily dose in Part 3 will not exceed the maximum daily dose tolerated in either Part 1 or 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy subjects between 18 and 65 years old.
- BMI between 18 and 33 kg/m2, inclusive, and a total body weight > 50 kg.
- All laboratory values must be within normal limits or any abnormalities deemed not clinically significant.
- All subjects must be willing to abstain from sexual intercourse or to use adequate contraception during the study and for an additional 120 days after the follow-up visit.
- Subjects must not donate ova or sperm during the study and for an additional 120 days after the follow-up visit
Key exclusion criteria (18 listed)
- For premenopausal female subjects: Irregular menstrual cycles; Amenorrhea; or Abnormal vaginal bleeding
- A history (within the past year) or presence of a clinically significant infectious disease or hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, neurologic, or psychiatric abnormality.
- Blood pressure > 160/95 at screening or on Day -1.
- Any active or uncontrolled infections or other medical condition or circumstance that could interfere with the subject's participation in the study.
- History of allergic reaction to mannitol.
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 |
|---|---|---|
| NVG-291NVG-291 is a drug injected under the skin (subcutaneous). | Drug | NVG-291 MAD, NVG-291 MAD - Males and Premenopausal Females, NVG-291 SAD |
| PlaceboSalt water is being used as a placebo and will be injected under the skin (subcutaneous). | Other | NVG-291 MAD, NVG-291 MAD - Males and Premenopausal Females, NVG-291 SAD |
Primary outcome
Adverse Events
Time frame: Assessed through 7 days following the last dose of study drug
number and frequency of adverse events
2 secondary outcomes
Pharmacokinetic analysis (plasma)
Time frame: Assessed on Day 1 (SAD and MAD) and Day 14 (MAD only)
Immunogenicity analysis
Time frame: Assessed on Day 1 (SAD and MAD), Day 8 (SAD and MAD) and Day 21 (MAD only)
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 10 Jan 2024.
- 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.
Daniel Miko, MD study director
CMO
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 NVG-291 in people with Spinal Cord Injury, run by NervGen Pharma at 1 site in Australia.
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 7 inclusion and 18 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 10 Jan 2024. 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 Australia. 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?
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?
Adverse Events (time frame: Assessed through 7 days following the last dose of study drug). 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 10 Jan 2024.