Healthy ParticipantsEarly Phase 1RH013001NCT04713319
Novel Energy Metabolic Signaling Molecule With Therapeutic Potential
A Early Phase 1 study testing Panavital in people with Healthy Participants, run by Petteri Hirvonen at 1 site in Finland.
Trial summary
Altogether a 25-day study. First 4 days non-blinded with water before 0-control blood samples (Day0). Thereafter blinded for 21 days (3 weeks). Study group was apparently healthy 50-60 -year-old males and females (N=27). Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Panavital
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteFinland
- Study dates
- 4 Oct 2019to 31 Dec 2021
- 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 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy 50-60 year-old females and males
Who cannot join
- history of cardiovascular diseases, overweight (BMI >32)
Trial locations and contacts
1 site in 1 country.
Finland1 site
Faculty of Sports and Health Sciences, University of Jyväskylä
Jyväskylä, Central Finland, FI-40014
About this study
Official title: Acute Health Effects of a Bout of Exercise in Physically Active Persons and Comparison to a Repetition With Natural Signalling Agent
Altogether a 25-day study. First 4 days non-blinded with water before 0-control blood samples (Day0). Thereafter blinded for 21 days (3 weeks). Study group was apparently healthy 50-60 -year-old males and females (N=27).
Read the detailed description
Blinded 21-day period was divided into two sub-periods (7 days and 14 days) and it included 3 measurement days. All measurements were on the same day of each week to facilitate maximal comparability (Day0, Day7 and Day21). Additionally on Day0 and Day7 there were acute measurements 45 minutes after morning "non-acute" resting and fasting blood samples. (In a "non-acute" measurement last dose of Panavital or placebo was taken 12 hours before the "non-acute" blood sample collected next morning .)
First week started with Day0 baseline measurements and immediately thereafter a strenuous VO2max test with 2 recovery days thereafter. After full recovery a 4-day blinded Panavital regimen. Last "non-acute" dose on Day6 was taken 12 hours before Day7 morning blood sample. At Day7 an acute 45 min placebo comparison was conducted.
Thereafter a 14-day follow-up period with halved Panavital dose or Placebo. Altogether 5 arterial blood samples were withdrawn. Three fasting and resting "non-acute" samples were taken in the morning before any treatments at Day0, Day7 and Day21. Two acute samples were collected after the VO2max (Day1) and after acute Panavital or placebo doses (Day7).
Additionally 5 fingertip blood samples for glucose (and lactate) were taken at the same time as arterial samples (Day0 and Day7) and one fingertip sample was taken immediately at the end of VO2max.
- Conditions
- Healthy Participants
- Being tested
- Panavital, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanavitalDrug
Also called D-glyceric acid calcium salt dehydrate
In the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water.
PlaceboOther
In the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Ten participants were randomly selected to the placebo group.
Calcium chloride (E509) dissolved into water. Extremely small equimolar calcium dose with the test item. Receives: Other: Placebo |
| RH013001 (DGA) | Active comparator | D-glyceric acid (DGA) calcium salt dehydrate (RH013001) dissolved into 1.8 dl of water. Effective dose of DGA was 3.33 mg / kg body weigh for the first 4 days. Thereafter the dose was reduced to half for the 14 days follow up period. Frequency: 2 times a day. Receives: Drug: Panavital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute change in blood IL-6, insulin, and glucose after RH013001 or Placebo dose at Day7
Immediately after morning (non-acute) blood sample therapeutic dose of RH013001 or placebo. Comparison of average response between RH013001 and placebo. Additional comparison to VO2max response (see pre-specified outcome below).
Measured: 45 minutes control blood sample
Change in blood metrices from Day1 (0-control / baseline) to Day7
Last dose 12 hours earlier = "non-acute". Paired comparison to Day1, measurements included energy metabolic and anti-inflammatory markers (first 3 days for recovery from VO2max), N in blinded placebo group was 0 for the first 7 days
Measured: 7 days
Secondary outcomes (2)
Global RNA-sequencing
From 3 "non-acute" blood samples (Day1, Day7 and Day21) white blood cells collected into Paxgene tubes.
Measured: 21 days
Change in "non-acute" blood sample metrices from Day1 (baseline) to Day21
Intra-group paired comparison to Day1 (paired t-test of the group averages), unpaired comparison of changes in group averages between placebo and RH013001 treatment.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start4 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Altogether a 25 day study with first four days non-blinded with water. There after 0-control blood samples. After the 0-control blinded treatments for 21 days (3 weeks). Study group apparently healthy 50-60 year old males and females (N=27).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petteri Hirvonen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Jyvaskyla
- Responsible party
- Sponsor-investigator, Petteri Hirvonen, Replicon Health Oy
- Investigators
- Heikki Kyröläinen, PhD, Study director, University of JyvaskylaPetteri Hirvonen, M.Sc., MBA, Principal investigator, University of Jyväskylä, Replicon Health Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713319
- Sponsor's protocol ID
- 2019_410211_2020
- Other IDs
- 2019
- Acronym
- RH013001
- Status last verified
- Oct 2022
- First submitted
- 13 Jan 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After deindentification of the individual data, we may share all the data that is reported in published articles. TIME FRAME: from 9 months to 36 months of the publication date. (Main data will be presented in the supplements of the articles.) Original Study Protocol and Study Plan for the Ethical Committee may also be shared. TO WHOM: researches who have been accepted by independent review committee for this purpose.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Health Effects of a Bout of Exercise in Physically Active Persons and Comparison to a Repetition With Natural Signalling Agent
- ClinicalTrials.gov ID
- NCT04713319
- Acronym / sponsor ID
- RH013001 / 2019_410211_2020
- Conditions
- Healthy Participants
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Petteri HirvonenIndustry (pharma, biotech, devices)
- Collaborators
- University of Jyvaskyla
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Jan 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.
Altogether a 25-day study. First 4 days non-blinded with water before 0-control blood samples (Day0). Thereafter blinded for 21 days (3 weeks). Study group was apparently healthy 50-60 -year-old males and females (N=27).
Detailed description
Blinded 21-day period was divided into two sub-periods (7 days and 14 days) and it included 3 measurement days. All measurements were on the same day of each week to facilitate maximal comparability (Day0, Day7 and Day21). Additionally on Day0 and Day7 there were acute measurements 45 minutes after morning "non-acute" resting and fasting blood samples. (In a "non-acute" measurement last dose of Panavital or placebo was taken 12 hours before the "non-acute" blood sample collected next morning .)
First week started with Day0 baseline measurements and immediately thereafter a strenuous VO2max test with 2 recovery days thereafter. After full recovery a 4-day blinded Panavital regimen. Last "non-acute" dose on Day6 was taken 12 hours before Day7 morning blood sample. At Day7 an acute 45 min placebo comparison was conducted.
Thereafter a 14-day follow-up period with halved Panavital dose or Placebo. Altogether 5 arterial blood samples were withdrawn. Three fasting and resting "non-acute" samples were taken in the morning before any treatments at Day0, Day7 and Day21. Two acute samples were collected after the VO2max (Day1) and after acute Panavital or placebo doses (Day7).
Additionally 5 fingertip blood samples for glucose (and lactate) were taken at the same time as arterial samples (Day0 and Day7) and one fingertip sample was taken immediately at the end of VO2max.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Altogether a 25 day study with first four days non-blinded with water. There after 0-control blood samples. After the 0-control blinded treatments for 21 days (3 weeks). Study group apparently healthy 50-60 year old males and females (N=27).
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboTen participants were randomly selected to the placebo group. Calcium chloride (E509) dissolved into water. Extremely small equimolar calcium dose with the test item. |
| RH013001 (DGA) | Active comparator | Drug: PanavitalD-glyceric acid (DGA) calcium salt dehydrate (RH013001) dissolved into 1.8 dl of water. Effective dose of DGA was 3.33 mg / kg body weigh for the first 4 days. Thereafter the dose was reduced to half for the 14 days follow up period. Frequency: 2 times a day. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy 50-60 year-old females and males
Key exclusion criteria (1 listed)
- history of cardiovascular diseases, overweight (BMI >32)
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 |
|---|---|---|
| PanavitalAlso: D-glyceric acid calcium salt dehydrateIn the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water. | Drug | RH013001 (DGA) |
| PlaceboIn the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water. | Other | Placebo |
Primary outcome
Acute change in blood IL-6, insulin, and glucose after RH013001 or Placebo dose at Day7
Time frame: 45 minutes control blood sample
Immediately after morning (non-acute) blood sample therapeutic dose of RH013001 or placebo. Comparison of average response between RH013001 and placebo. Additional comparison to VO2max response (see pre-specified outcome below).
Change in blood metrices from Day1 (0-control / baseline) to Day7
Time frame: 7 days
Last dose 12 hours earlier = "non-acute". Paired comparison to Day1, measurements included energy metabolic and anti-inflammatory markers (first 3 days for recovery from VO2max), N in blinded placebo group was 0 for the first 7 days
2 secondary outcomes
Global RNA-sequencing
Time frame: 21 days
Change in "non-acute" blood sample metrices from Day1 (baseline) to Day21
Time frame: 21 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 26 Oct 2022.
- Individual participant dataSharing planned: No. After deindentification of the individual data, we may share all the data that is reported in published articles. TIME FRAME: from 9 months to 36 months of the publication date. (Main data will be presented in the supplements of the articles.) Original Study Protocol and Study Plan for the Ethical Committee may also be shared. TO WHOM: researches who have been accepted by independent review committee for this purpose.
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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.
Heikki Kyröläinen, PhD study director
University of Jyvaskyla
Petteri Hirvonen, M.Sc., MBA principal investigator
University of Jyväskylä, Replicon Health Oy
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 Panavital in people with Healthy Participants, run by Petteri Hirvonen at 1 site in Finland.
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 1 inclusion and 1 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 26 Oct 2022. 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 Finland. 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?
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?
Acute change in blood IL-6, insulin, and glucose after RH013001 or Placebo dose at Day7 (time frame: 45 minutes control blood sample). 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 26 Oct 2022.